Details for New Drug Application (NDA): 091191
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NDA 091191 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Norvium Bioscience, Ryan Labs, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty NDAs. It is available from fifteen suppliers. Additional details are available on the LETROZOLE profile page.
The generic ingredient in LETROZOLE is letrozole. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
The generic ingredient in LETROZOLE is letrozole. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Pharmacology for NDA: 091191
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 091191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LETROZOLE | letrozole | TABLET;ORAL | 091191 | ANDA | Dr. Reddy's Laboratories Limited | 55111-646 | 55111-646-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30) |
| LETROZOLE | letrozole | TABLET;ORAL | 091191 | ANDA | Dr. Reddy's Laboratories Limited | 55111-646 | 55111-646-78 | 10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jun 3, 2011 | TE: | AB | RLD: | No | ||||
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