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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 210227


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NDA 210227 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 210227
Tradename:MEDROXYPROGESTERONE ACETATE
Applicant:Xiromed
Ingredient:medroxyprogesterone acetate
Patents:0
Pharmacology for NDA: 210227
Medical Subject Heading (MeSH) Categories for 210227
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral, Synthetic
Suppliers and Packaging for NDA: 210227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 210227 ANDA Amneal Pharmaceuticals NY LLC 60219-1467 60219-1467-1 1 VIAL in 1 CARTON (60219-1467-1) / 1 mL in 1 VIAL
MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTABLE;INJECTION 210227 ANDA Amneal Pharmaceuticals NY LLC 60219-1467 60219-1467-2 25 VIAL in 1 CARTON (60219-1467-2) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/ML
Approval Date:Oct 12, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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