Details for New Drug Application (NDA): 078058
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NDA 078058 describes ANASTROZOLE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Beijing Yiling, Chartwell Molecular, Chartwell Rx, Cipla, Eugia Pharma, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Natco Pharma Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the ANASTROZOLE profile page.
The generic ingredient in ANASTROZOLE is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.
The generic ingredient in ANASTROZOLE is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.
Summary for 078058
| Tradename: | ANASTROZOLE |
| Applicant: | Teva Pharms |
| Ingredient: | anastrozole |
| Patents: | 0 |
Pharmacology for NDA: 078058
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 078058
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANASTROZOLE | anastrozole | TABLET;ORAL | 078058 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7536 | 0093-7536-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7536-56) |
| ANASTROZOLE | anastrozole | TABLET;ORAL | 078058 | ANDA | AvKARE | 42291-085 | 42291-085-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-085-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jun 28, 2010 | TE: | AB | RLD: | No | ||||
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