Details for New Drug Application (NDA): 075671
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NDA 075671 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 075671
| Tradename: | MEGESTROL ACETATE |
| Applicant: | Strides Pharma |
| Ingredient: | megestrol acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075671
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 075671 | ANDA | Pharmaceutical Associates, Inc. | 0121-0945 | 0121-0945-00 | 10 TRAY in 1 CASE (0121-0945-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10) |
| MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 075671 | ANDA | Pharmaceutical Associates, Inc. | 0121-0945 | 0121-0945-40 | 4 TRAY in 1 CASE (0121-0945-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
| Approval Date: | Jul 25, 2001 | TE: | AB | RLD: | No | ||||
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