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.
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 |
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 | Mylan Institutional LLC | 67457-887 | 67457-887-01 | 25 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00) |
| MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 210227 | ANDA | Mylan Institutional LLC | 67457-887 | 67457-887-99 | 1 VIAL in 1 CARTON (67457-887-99) / 1 mL in 1 VIAL (67457-887-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/ML | ||||
| Approval Date: | Oct 12, 2018 | TE: | AB | RLD: | No | ||||
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