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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077235


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NDA 077235 describes MEDROXYPROGESTERONE ACETATE, which is a drug marketed by Amneal, Amphastar Pharms Inc, Cipla, Eugia Pharma, Hikma, Hong Kong, Sandoz, Sun Pharm, Teva Pharms Usa, Xiromed, Barr, Duramed Pharms Barr, and Upsher Smith Labs, and is included in sixteen NDAs. It is available from twenty-one suppliers. Additional details are available on the MEDROXYPROGESTERONE ACETATE profile page.

The generic ingredient in MEDROXYPROGESTERONE ACETATE is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.
Summary for 077235
Pharmacology for NDA: 077235
Suppliers and Packaging for NDA: 077235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 077235 ANDA Amphastar Pharmaceuticals, Inc. 0548-5400 0548-5400-00 1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5400-00) / 1 mL in 1 VIAL, SINGLE-DOSE
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 077235 ANDA Amphastar Pharmaceuticals, Inc. 0548-5400 0548-5400-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0548-5400-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/ML
Approval Date:Nov 28, 2017TE:ABRLD:No

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