Details for New Drug Application (NDA): 020726
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The generic ingredient in FEMARA is letrozole. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Summary for 020726
| Tradename: | FEMARA |
| Applicant: | Novartis Pharms |
| Ingredient: | letrozole |
| Patents: | 0 |
Pharmacology for NDA: 020726
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 020726
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEMARA | letrozole | TABLET;ORAL | 020726 | NDA | Novartis Pharmaceuticals Corporation | 0078-0249 | 0078-0249-15 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jul 25, 1997 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020726
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis Pharms | FEMARA | letrozole | TABLET;ORAL | 020726-001 | Jul 25, 1997 | 4,978,672 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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