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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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material_safety_data_sheet_letter_new_.doc
® (Fluorometholone, Ophthalmic Ointment) 0.1% ALBALON® (Naphazoline HCl Ophthalmic Solution) 0.1% FML- S® (Fluorometholone, Sulfacetamide Sodium Ophthalmic Suspension) ALLERGAN® Eye Wash Gentamicin Sulfate, 0.3% ALOCRILO (Nedocromil Sodium Ophthalmic Solution 2%) HYLAFORM® (Hylan B Gel) BLEPH- 10® (Sulfacetamide Sodium Ophthalmic Solution) 10...
author: hutton_ronald
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material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
API DIVISION" "AMOXICILLIN MFG IN MEXICO, MISSOURI" 13520 01-Sep-98 ANTIBIOTICOS TETRACYCLINE PHOSPHATE COMPLEX 13521 01-Sep-98 KYOWA HAKKO MITOMYCIN 13523 01-Sep-98 GIST BROCADES (IT) NYSTATIN 13527 01-Sep-98 BRISTOL MYERS SQUIBB INDUSTRIAL DIV AMIKACIN SULFATE 13535 01-Sep-98 MEIJI SEIKA KAISHA L PENICILLIN G PROCAINE 13536 01-Sep-98 ALPHARMA APS POLYMYXIN B ...
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Drug Approvals - M
NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50-679/S007 1/27/99 - - 7/18/01 Maxitrol (neomycin...
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Drug Approvals - B
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
- ANDA 76-476 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 &...
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Drug Approvals - N
ANDA 76-072 1/30/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx Teva Pharmaceuticals ANDA 76-037 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx Ivax Pharmaceuticals ANDA 75-763 9/16/03 - Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved Ivax Pharmaceuticals ANDA 75-763 6/11/03 -...
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FDA Drug Approvals List February 2002
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated...
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Prescription and OTC Drug Product List 1/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
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Prescription and OTC Drug Product List 5/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
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Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
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PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
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Prescription Drug Product List 1/96
PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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http://www.fda.gov/cder/rdmt/escy99ap.htm
- - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)
- - - - - - - - - - ALBUTEROL SULFATE 3M PHARMACEUTICALS 20-503 06/02/98 06/02/99 SE1 11 N 12.0 Provides for lowering the age from 12 years to 4 years and...
author: Darlene
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February Drug Approvals
Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal...
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FDA Drug Approvals List July 1999
Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
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FDA Drug Approvals List August 1999
Original Application #: 020997 Approval Date: 05-AUG-99 Trade Name: CHIROCAINE Chemical Type: 2 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DARWIN DISCOVERY LTD Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For surgical anesthesia and pain management for adults Original Application #: 020902 Approval Date: 05-AUG-99 Trade...
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FDA Drug Approvals List- December 1998
Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
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DDPA December 1995
20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
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DDPA August 1996
74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM 20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG CANADA (NONSTEROIDAL ANTI-INFLAMMATORY) 74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR 30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG 43216 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID 01-AUG-96 (TABLET) LAURELTON, NY 100MG 11413 300MG (LABELING...
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Drug Approvals November 1996
Application #: 050580; Efficacy Supplement #: 008 Type: SE1 to Original New Drug Application Approval Date: 01-NOV-96 Trade Name: AZACTAM Dosage Form: INJECTABLE Applicant: ER SQUIBB AND SONS INC Active Ingredient(s): AZTREONAM OTC/RX Status: RX Efficacy Claim: Expanded use of Azactam in pediatric patients Application #: 019918; Efficacy Supplement #: 004 Type: SE1 to Original...
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August Drug Approvals
Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
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Drug Approvals for September 1997
The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s):...
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Antibiotics
-- Search - Biochemicals Amino Acids Antibiotics Biological Buffers Detergents Enzyme Substrates Inorganic Reagents Molecular Biology Organic Reagents Stains & Dyes Vitamins ---- You are here: Home » Biochemicals » Antibiotics Antibiotics 1 - 46 of 46 1 17-AAG...
')" onMouseOut="hideTip()" href="Product.aspx?ProdId=24401">Ascomycin A3680 Highly Purified Form:-- Supplied...
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