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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
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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 MALLINCKRODT...
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http://www.fda.gov/cder/foi/appletter/2000/75666ltr.pdf
ANDA 75- 666 May 24, 2000 Clay- Park Labs, Inc
Bronx, NY 10457 Dear Madam: This is in reference to your abbreviated new drug application dated July 8, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Hydrocortisone Valerate Cream USP, 0.2%
We have completed the review of this abbreviated application and have...
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http://www.fda.gov/cder/foi/appletter/2000/75666ltr.pdf page 1
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H: 43.PDF page 1
author: Unknown
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H: 42.PDF page 1
author: Unknown
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74489ltr
ANDA 74- 489 August 12, 1998 Copley Pharmaceutical, Inc
Nudelman 25 John Road Canton, MA 02021 Dear Sir: This is in reference to your abbreviated new drug application dated March 28, 1994, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Hydrocortisone Valerate Cream USP, 0.2%
We have completed the review of this abbreviated...
author: Unknown
subject: 74489
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74489ltr page 1
author: Unknown
subject: 74489
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Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library anti-itch medications, antipruritic medications,...
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DOCUMENT INFORMATION PAGE page 4
author: CDER USER
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DOCUMENT INFORMATION PAGE page 1
author: CDER USER
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C:\Data\My Documents\N18726S009S012APltr.doc page 4
author: Mary Jean Kozma Fornaro
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C:\Data\My Documents\N18726S009S012APltr.doc page 1
author: Mary Jean Kozma Fornaro
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1996 and Older - New Drug Application (NDA)
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5/2003 Humulin R Lilly 018870/S37 1/11/1994 6/17/2003 Hydrocortisone and Acetic Acid - Morton Grove Pharmaceuticals 040168 08/30/1996 8/1/2003 Hyzaar ...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
CHICAGO, ILL FACIL" 4537 07-Apr-82 DIPHARMA FRANCIS SPA HYDROFLUMETHIAZIDE USP 4538 07-Apr-82 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA DIPHENYLHYDANTOIN SODIUM SALT 4539 17-May-82 R MASON CHEMICALS LTD SELENIUM DISULFIDE 4555 17-Mar-82 AJINOMOTO USA INC "AMINO ACIDS MANUFACTURED IN RALEIGH, NORTH CAROLINA." 4561 12-May-82 FINE CHEMICALS CORPORATION VINCRISTINE SULPHATE...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
PROPRANOLOL HCL TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT AND EXPORT CO METHOCARBAMOL MFG BY XIN XIN PHARMACEUTICAL MANUFACTORY SOCIETA ITALIANA CORTICOSTEROIDI SPA BETAMETHASONE VALERATE INDUSTRIA CHIMICA MILANESE SPA THIORIDAZINE HYDROCHLORIDE INDUSTRIA CHIMICA MILANESE SPA FLUPHENAZINE HcL MALLINCKRODT INC THALLOUS CHLORIDE TI 201 INDUSTRIA CHIMICA MILANESE SPA PERPHENAZINE...
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ANDAs Approvals - May 2000
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1
5/1/00 TABLETS 80 MG 120 MG 160 MG 240 MG 2
75-429 SOTALOL HYDROCHLORIDE TEVA PHARMACEUTICALS USA 5/1/00 TABLETS 80 MG 120 MG 160 MG 240 MG 4
5/2/00 ATROPINE SULFATE TABLETS, USP 2.5 MG/0.025 MG 5
5/4/00 (OTC) 75 MG 7
author: USERNAME
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75043_Hydrocortisone.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Hydrocortisone Valerate Ointment, USP Company:- Taro Pharmaceuticals Inc
Application No.:- 75-043 Approval Date:-8/25/1998 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - - Back to...
author: Paul Stauffer
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74489_Hydrocortisone.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Hydrocortisone Valerate Cream, USP Company:- Copley Pharmaceutical, Inc
Application No.:- 74-489 Approval Date:-8/12/1998 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - - Back to...
author: Paul Stauffer
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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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...
author: SSCI Webmaster
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FDA Drug Approvals List- August 1998
Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074951 Approval Date: 31-AUG-98 Trade Name: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE Dosage Form: CAPSULE Applicant: JEROME STEVENS PHARMACEUTICALS INC Active Ingredient(s): ASPIRIN; BUTALBITAL; CAFFEINE; AND CODEINE PHOSPHATE OTC/RX Status: RX Original...
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Drug Approvals for July 1997
Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
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