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 ...
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 INTENSOL,...
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...
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...
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
author: USERNAME
75043_Hydrocortisone.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Hydrocortisone Valerate Ointment, USP Company:- Taro Pharmaceuticals Inc
author: Paul Stauffer
74489_Hydrocortisone.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Hydrocortisone Valerate Cream, USP Company:- Copley Pharmaceutical, Inc
author: Paul Stauffer
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...
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
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...
http://www.fda.gov/cder/foi/appletter/2000/75666ltr.pdf ANDA 75- 666 May 24, 2000 Clay- Park Labs, IncHydrocortisone Valerate Cream USP, 0.2%
http://www.fda.gov/cder/foi/appletter/2000/75666ltr.pdf page 1
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...
H: 43.PDF page 1
author: Unknown
H: 42.PDF page 1
author: Unknown
74489ltr ANDA 74- 489 August 12, 1998 Copley Pharmaceutical, IncHydrocortisone Valerate Cream USP, 0.2%
author: Unknown
subject: 74489
74489ltr page 1
author: Unknown
subject: 74489
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...
C:\Data\My Documents\NDA\9402\slr37.ap.doc NDA 09- 402/ S- 037 and 039 Page 3 DELESTROGEN ® (ESTRADIOL VALERATE INJECTION, USP) ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important
author: Kassandra C. Sherrod
C:\Data\My Documents\NDA\9402\slr37.ap.doc page 1
author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
C:\Data\My Documents\NDA\9402\slr37.ap.doc NDA 09- 402/ S- 037 and 039 Page 3 DELESTROGEN ® (ESTRADIOL VALERATE INJECTION, USP) ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important
author: Kassandra C. Sherrod
http://www.euroscreen.be/PDF/GPR43.pdf Functional Characterization of Human Receptors for Short Chain Fatty Acids and Their Role in Polymorphonuclear Cell Activation* Received for publication, February 10, 2003, and in revised form, April 22, 2003 Published, JBC Papers in Press, April 23, 2003, DOI 10.1074/ jbc
http://www.euroscreen.be/PDF/GPR43.pdf page 6
http://www.repromed.com.au/DOCUMENTS/statement.pdf Information Statement Table of Contents i Welcome to 1 Out of Hours Contact 1 Legal Aspe 2 Health and 4 Counselling and Support 5 Medications 6 Ovulation 8 Intra Uterine Insemination 10 Donor Sperm Program (DI) 12 IVF, ICSI Treatment 13 § How many eggs to be Inseminated
Alefacept (Amevive) Clinical Review page 26
author: CBER FDA
subject: dob062703
