http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL...
Orange Book Preface FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH APPROVED DRUG PRODUCTS with Therapeutic Equivalence Evaluations 24th Edition PREFACE The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List), identifies drug products approved on the...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "HYDROCHLOROTHIAZIDE MANUFACTURED IN MILAN, ITALY." 883 18-Mar-65 CAMBREX PROFARMACO MILANO S.R.L
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls HYDROCHLOROTHIAZIDE MANUFACTURED IN MILAN, ITALYHYDROCHLOROTHIAZIDE USP SOLMAG S.P.A PHENDIMETRAZINE TARTRATE SIFAVITOR...
Approved Drug Products Preface, 21st edition Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search Food and Drug Administration Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations PREFACE TO TWENTY SECOND EDITION - The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List), identifies drug...
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1997 New Drug Application (NDA) Searle and Company 020607 12/24/1997 4/30/2002 Asacol Mesalamine Procter and Gamble 019651/S005 8/19/1997 6/18/2003 Ativan/Lorazepam [11.8 MB] Wyeth-Ayerst Laboratories 018140/S003 10/5/1997 12/17/1997 Avapro/Irbesartan and Irbesartan and Hydrochlorothiazide Approval Letter [210 KB] Medical Letter Part 1 [4.9 MB], Part 2 [4 MB] Part 3 [4 MB], Part 4 [3.8 MB] Chemistry Review(s)...
1997 Abbreviated New Drug Applications (Generic Drugs) 74748 5/23/97 4/9/99 Captopril & Hydrochlorothiazide Tablets USP, 25mg/15mg, 50mg/15mg, 25mg/25mg, & 50mg/25mgHydrochlorothiazide Tablets USP, 50 mg/25 mgHydralazine Hydrochloride Injection USP, 20 mg/mL
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
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Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
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...
Prescription and OTC Drug Product List 3/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
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...
Drug Approvals for June 1997 Drug Approvals for June 1997 Definitions and Notes June 1997 Original New Drug Applications Original Application #: 020729 Approval Date: 27-JUN-97 Trade Name: UNIRETIC Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status: RX Indication(s): Treatment of...
http://www.fda.gov/cder/da/ddpa93.wpd 73 138 TRAZODONE HCL MUTUAL PHARM TRAZODONE HYDROCHLORIDE 03 23 93 (TABLET) PHILADELPHIA, PA 150MG 19124 (ANTIDEPRESSANT) 73-653 METOPROLOL TARTRATE MUTUAL PHARM METOPROLOL TARTRATE 03-30-93 (TABLET) PHILADELPHIA, PA 50MG 19124 (BETA ADRENERGIC BLOCKER) 73-654 METOPROLOL TARTRATE MUTUAL PHARM METOPROLOL TARTRATE 03-30-93 (TABLET) PHILADELPHIA, PA 100MG 19124 (BETA ADRENERGIC...
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)...
