http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
What's new at CDER by Date - U.S
author: Paul Stauffer
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategD.pdf page 4 4 PHENYL SEPHAROSE PHENYLALANINE ( L, D, or D/ L) PHLEOMYCIN PHOSPHATIDIC ACIDS (L- a-) PHOSPHATIDYL INOSITOL PHOSPHATIDYLCHOLINE / LECITHIN PHOSPHATIDYLETHOLAMIDE LPHOSPHATYDYLCHOLINE DIPALMITOYL (LPHOSPHOENOLPYRUVATE / PEP PHOSPHOGLUCONIC ACID PHOSPHOGLYCERIC ACID (D(-) 3-) PHOSPHOGLYCOLIC ...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
http://www.fda.gov/cder/da/ddpa93.wpd 19 050 SUFENTA JANSSEN SUFENTANIL CITRATE 03 19 93 (INJECTABLE) PISCATAWAY, NJ EQ 0.05MG BASE/ML 08854 (REVISED LABELING DESCRIPTION; CLINICAL PHARMACOLOGY; CLINICAL STUDIES; INDICATIONS AND USAGE; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE; DOSAGE AND ADMINISTRATION) 19 898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM 03 22 93 (TABLET) PRINCETON, NJ 10MG 08543 20MG...
http://www.fda.gov/cder/da/ddpa91.wpd DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20 057 CEREDASE GENZYME ALGLUCERASE 04 05-91 (INJECTABLE) BOSTON, MA 80 UNITS/ML (1 A, V*) 02111 (BETA-GLUCOCEREBROSIDASE ENZYME...
http://www.fda.gov/cder/da/ddpa92.wpd 20 005 CARDENE SR SYNTEX NICARDIPINE HYDROCHLORIDE 01 23 92 (CAPSULE, PALO ALTO, CA 30MG EXTENDED RELEASE) 94304 45MG 60MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 73 243* LOPERAMIDE HCL PERRIGO LOPERAMIDE HYDROCHLORIDE 01 21 92 (SOLUTION) ALLEGAN, MI 1MG/5ML 49010 (ANTIDIARRHEAL) (OTC) 81 264 BENZTROPINE MESYLATE MUTUAL PHARM BENZTROPINE MESYLATE 01 23 92 (TABLET) PHILADELPHIA,...
CDER: Previous News Items, 2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items, 2004 February 6, 2004 -FDA approves Oxycodone Hydrochloride (non combination product) February 5, 2004 FDA approves first-time generic TriLyte (Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate and Sodium Chloride ...
DDPA February 1995 Drug and Device Product Approvals for February 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-797 NULYTELY-FLAVORED BRAINTREE POLYETHYLENE GLYCOL 3350 18-NOV-94 (POWDER BRAINTREE, MA 420GM/BOT (SUPPL-002)FOR RECONSTITUTION) 02184 POTASSIUM CHLORIDE 1.48GM/BOT SODIUM BICARBONATE 5.72GM/BOT SODIUM CHLORIDE 11.2GM/BOT ...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol ...
2-144 Formulations vs 2 page 2
2-144 Formulations vs 2 page 1
2-134 Formulations vs 2 page 2
2-134 Formulations vs 2 page 1
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
Products: listing products PDB 50 L $1,250.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 50 L $1,250.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE...
Products: listing products PDB 50 L $1,250.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 50 L $1,250.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt SILVER SULFADIAZINE 4298 22-Oct-81 SCHERING PLOUGH AVONDALE CO DEXCHLORPHENIRAMINE MALEATE 4305 22-Oct-81 LOFTUS BRYAN CHEMICALS LTD CHLORPHENIRAMINE MALEATE 4312 21-Oct-81 SCHERING PLOUGH AVONDALE CO DEXBROMPHENIRAMINE MALEATE 4313 03-Nov-81 AVECIA INC "SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA." 4317 15-Oct-81 SCHERING PHARMACEUTICAL...
http://www.paddocklabs.com/forms/secundum/volume_5_3.pdf Formula 2 (with PEG) Acyclovir (200 mg Caps) 6 Polyethylene Glycol 3350 6Polyethylene Glycol 4000 1 g Polyethylene Glycol 400 2POLYETHYLENE GLYCOLS ITEM MELTING POINT °C CONGEALING POINT °C Waxes...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
HLPressRelease has announced that the HalfLytely ® and Bisacodyl Tablets Bowel Prep Kit (PEG- 3350, sodium chloride, sodium bicarbonate, potassium chloride for oral solution and bisacodyl delayed release tablets) is available nationwide as a prescription preparation for bowel cleansing prior to colonoscopy.
author: JLUMSDEN
subject: HLPressRelease
Dry Chemicals Size ACES, High Purity Grade 0400-5-65 100 g ACES, High Purity Grade 0400-5-70 500 g Acetamide, 99% 0610-5-65 100 g Acetamide, 99% 0610-5-70 500 g o-Acetylsalicylic Acid, 99% 0680-5-65 100 g o-Acetylsalicylic Acid, 99% 0680-5-70 500 g bis-Acrylamide, Ultra Pure 5040-5-65 100 g bis-Acrylamide, Ultra Pure 5040-5-58 25 g Adipic Acid, 99% 0770-5-65 100 g Adipic Acid, 99% 0770-5-70 500 g...
OTC Drug Review Ingredient Status JANUARY 1984 EDITION AUGUST 1985 AND NOVEMBER 1986 EDITION 8- Hydroxyquinoline Oxyquinoline Acetanilid Acetanilide Alcohol 14 percent Alcohol Alkaloids of Sabadilla Sabadilla Alkaloids Alkyldimethyl Benzylammonium Chloride Benzalkonium Chloride Alum Alum, Ammonium and Alum, Potassium Alum Ammonium Alum, Ammonium Alum (Powdered Alum) Alum, Ammonium and Alum , ...
author: Paul Stauffer
