05-03-02 - Baxter Announces Approval of Diltiazem for Injection Conditions Therapies Products Services About Baxter Baxter Worldwide > United States Training and Education Sustainability Contact Us - << Back to News Releases 2005 Archives 2004 Archives 2003 Archives 2002 Archives 2001 Archives News Release Home > About Baxter > News Room > News Releases BAXTER ANNOUNCES APPROVAL OF 25mL PRESENTATION OF DILTIAZEM HYDROCHLORIDE for...
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET,...
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...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
First-Time Generics - December 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INCDILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE...
author: OGD
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
Prescription and OTC Drug Product List 6/2002 45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN ...
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN...
http://www.fda.gov/cder/foi/appletter/2000/75004ltr.pdf ANDA 75- 004 February 16, 2000 Abbott Laboratories Hospital Products Division Attention: Leslie Koehler 200 Abbott Park Road, D389 AP30 Abbott Park, IL 60064 Dear Madam: This is in reference to your abbreviated new drug application dated November 11, 1996, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Diltiazem Hydrochloride ...
http://www.fda.gov/cder/foi/appletter/2000/75004ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/1999/75116ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/1999/74984ltr.pdf 200 Elmora Avenue Elizabeth, NJ 07207 Dear Madam: This is in reference to your abbreviated new drug application dated October 11, 1996, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Diltiazem Hydrochloride Extended- release Capsules USP (Once- a- Day Dosage), 120 mg, 180 mg, 240 mg and 300 mg
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http://www.fda.gov/cder/foi/appletter/1999/74984ltr.pdf page 1
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
http://www.fda.gov/cder/foi/appletter/1999/74845ltr.pdf Washington, DC 20001 Dear Sir: This is in reference to your abbreviated new drug application dated January 31, 1996, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Diltiazem Hydrochloride Extended- release Capsules USP, 60 mg, 90 mg, and 120 mg (Twice a Day Dosage)Diltiazem ...
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author: Unknown
DDPA September 1995 74-483 CAPTOPRIL LEMMON CAPTOPRIL 29-SEP-95 (TABLET) SELLERSVILLE, PA 12.5MG 18960 25MG 50MG 100MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-036 AREDIA CIBA GEIGY PAMIDRONATE DISODIUM 01-SEP-95 (INJECTABLE) SUMMIT, NJ 30MG/VIAL 07901 60MG/VIAL 90MG/VIAL (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; PRECAUTIONS;...
DDPA August 1995 74-462 CAPTOPRIL COPLEY PHARMA CAPTOPRIL 24-AUG-95 (TABLET) CANTON, MA 12.5MG 02021 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-505 CAPTOPRIL WESTWARD CAPTOPRIL 31-AUG-95 (TABLET) EATONTOWN, NJ 12.5MG 07724 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-766 ZOCOR MERCK SIMVASTATIN 01-AUG-95 (TABLET) WEST POINT...
DDPA May 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 50-521 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE 46285 EQ 500MG BASE (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS) 50-522 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML FOR RECONSTITUTION) 46285 EQ 187MG BASE/5ML EQ 250MG BASE/5ML EQ 375MG BASE/5ML ...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO...
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): Treatment...
