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-two 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-five 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-five 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 |
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: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/ML | ||||
| Approval Date: | Jan 5, 2023 | TE: | RLD: | No | |||||
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