Details for New Drug Application (NDA): 074621
✉ Email this page to a colleague
NDA 074621 describes MEGESTROL ACETATE, which is a drug marketed by Bionpharma, 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 thirteen 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 074621
| Tradename: | MEGESTROL ACETATE |
| Applicant: | Barr |
| Ingredient: | megestrol acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074621
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074621 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0606 | 0555-0606-02 | 100 TABLET in 1 BOTTLE (0555-0606-02) |
| MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074621 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0607 | 0555-0607-02 | 100 TABLET in 1 BOTTLE (0555-0607-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Nov 30, 1995 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 16, 1996 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
