http://www.fda.gov/cder/orange/appendix_a.txt
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ANDA 40- 402 August 30, 2001 Able Laboratories Inc Attention: Shashikant Shah 6 Hollywood Court South Plainfield, NJ 07080- 4295 Dear Sir: This is in reference to your abbreviated new drug application dated February 10, 2000, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Phentermine Hydrochloride Tablets USP, 37.5 mg
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ANDA 40- 276 November 25, 1998 Purepac Pharmaceutical Co Elizabeth, NJ 07207 Dear Madam: This is in reference to your abbreviated new drug application dated September 11, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Phentermine Hydrochloride Tablets USP, 37.5 mg We have completed the review of this abbreviated...
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author: Biosite Incorporated
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
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FDA Drug Approvals List August 2001
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040427 Tentative Approval Date: 30-AUG-01 Trade Name: PHENTERMINE HYDROCHLORIDE Dosage Form: CAPSULE Applicant:ABLE LABORATORIES, INC Active Ingredient(s): PHENTERMINE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040402...
Drug Approvals for May 1997
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FDA Drug Approvals List
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http://www.fda.gov/cber/gdlns/guidelst.txt
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http://www.fda.gov/cber/gdlns/anguidlst.txt
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