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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 214309


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NDA 214309 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 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 214309
Tradename:MEDROXYPROGESTERONE ACETATE
Applicant:Hikma
Ingredient:medroxyprogesterone acetate
Patents:0
Pharmacology for NDA: 214309
Suppliers and Packaging for NDA: 214309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 214309 ANDA Hikma Pharmaceuticals USA inc. 24201-150 24201-150-01 1 VIAL in 1 CARTON (24201-150-01) / 1 mL in 1 VIAL (24201-150-00)
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 214309 ANDA Hikma Pharmaceuticals USA inc. 24201-150 24201-150-25 25 VIAL in 1 CARTON (24201-150-25) / 1 mL in 1 VIAL (24201-150-00)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength150MG/ML
Approval Date:Jan 5, 2023TE:RLD:No

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