Details for New Drug Application (NDA): 210760
NDA 210760 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 is one drug master file entry 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 is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.
Summary for 210760
| Tradename: | MEDROXYPROGESTERONE ACETATE |
| Applicant: | Sun Pharm |
| Ingredient: | medroxyprogesterone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210760
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 210760 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-090 | 62756-090-40 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-090-40) / 1 mL in 1 VIAL, SINGLE-DOSE |
| MEDROXYPROGESTERONE ACETATE | medroxyprogesterone acetate | INJECTABLE;INJECTION | 210760 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-090 | 62756-090-45 | 25 VIAL, SINGLE-DOSE in 1 CARTON (62756-090-45) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/ML | ||||
| Approval Date: | May 1, 2019 | TE: | RLD: | No | |||||
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