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 importantDELESTROGEN ® (estradiol valerate injection, USP) contains estradiol valerate, a long- acting estrogen in sterile oil...
author: Kassandra C. Sherrod
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author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
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 importantDELESTROGEN ® (estradiol valerate injection, USP) contains estradiol valerate, a long- acting estrogen in sterile oil...
author: Kassandra C. Sherrod
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
Prescription and OTC Drug Product List 6/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 6: June 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL OXYCODONE AND ACETAMINOPHEN CAPOZIDE 25/15 - ADD - AA DURAMED 325MG;5MG N40272 001 - ADD - AB BRISTOL...
FDA Drug Approvals List- June 1998 Drug Approvals for June 1998 Definitions and Notes June 1998 Original New Drug Applications Original Application #: 020865 Approval Date: 29-JUN-98 Trade Name: MAXALT - MLTRA ISC Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC Active Ingredient(s): RIZATRIPTAN BENZOATE OTC/RX Status: RX Indication(s): Acute...
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...
Estrogen therapy for dysfunctional uterine bleeding - [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 Estrogen therapy for dysfunctional uterine bleeding - [Medication] - Quest Diagnostics Patient Health Library Estrogen therapy for dysfunctional uterine bleeding - [Medication] - Quest Diagnostics Patient Health Library Conjugated Estrogen, Conjugated...
Drug Approvals - D Delestrogen (estradiol valerate) Injection, USP King Pharmaceuticals NDA 9-402/S37 & S39 12/12/03 12/16/03 12/16/03 Delflex Standard and Low Magnesium and Delflex PD Solution Low Calcium/Low Magnesium Peritoneal Solution, Fresenius Medical NDA 18-883/S28 & 20-171/S10 11/26/03 12/2/03 Delsym (Dextromethorphan Polistirex) Extended-Release Suspension Celltech Americas, Inc...
Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Estrogen and Estrogen with Progestin-Therapies for-Postmenopausal Women The Food and Drug Administration has received requests from the public to provide updated product information for estrogen- and progestin-containing drug products used for treating postmenopausal symptoms
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author: Kassandra C. Sherrod
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author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
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author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
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author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
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author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
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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 page 11
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 page 5
author: Kassandra C. Sherrod
duplicates:http://www.fda.gov/cder/foi/label/2003/09402slr037_delestrogen_lbl.pdf
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author: Kassandra C. Sherrod
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author: Kassandra C. Sherrod
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JUN_1998.HTML Reference Listed Drug Labeling Approved in June 1998 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt URSODEOXYCHOLIC ACID 3326 20-Oct-78 MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST 3328 14-Jun-78 ACRAF TRAZODONE HCL 3351 31-Oct-78 ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE 3353 10-Nov-78 GEDEON RICHTER LTD NORETHISTERONE 3364 29-Aug-78 DINAMITE DIPHARMA SPA FUROSEMIDE USP 3379 02-Nov-78 SCHERING AG ESTRADIOL -VALERATE 3391 31...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL -VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE...
