Details for New Drug Application (NDA): 203139
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NDA 203139 describes MEGESTROL ACETATE, which is a drug marketed by Chartwell, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from sixteen suppliers. Additional details are available on the MEGESTROL ACETATE profile page.
The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 203139
| Tradename: | MEGESTROL ACETATE |
| Applicant: | Twi Pharms |
| Ingredient: | megestrol acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139 | ANDA | TWi Pharmaceuticals, Inc. | 24979-041 | 24979-041-13 | 150 mL in 1 BOTTLE (24979-041-13) |
| MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139 | ANDA | Proficient Rx LP | 71205-943 | 71205-943-15 | 150 mL in 1 BOTTLE (71205-943-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 125MG/ML | ||||
| Approval Date: | Aug 27, 2014 | TE: | AB | RLD: | No | ||||
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