Details for New Drug Application (NDA): 091643
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NDA 091643 describes FINASTERIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Natco Pharma, Sun Pharm, Teva, Zydus Pharms Usa Inc, and Zydus Lifesciences, and is included in twenty-three NDAs. It is available from thirty-four suppliers. Additional details are available on the FINASTERIDE profile page.
The generic ingredient in FINASTERIDE is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.
The generic ingredient in FINASTERIDE is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.
Summary for 091643
| Tradename: | FINASTERIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | finasteride |
| Patents: | 0 |
Pharmacology for NDA: 091643
| Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091643
Suppliers and Packaging for NDA: 091643
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINASTERIDE | finasteride | TABLET;ORAL | 091643 | ANDA | Accord Healthcare, Inc. | 16729-089 | 16729-089-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-089-10) |
| FINASTERIDE | finasteride | TABLET;ORAL | 091643 | ANDA | Accord Healthcare, Inc. | 16729-089 | 16729-089-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-089-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Nov 5, 2013 | TE: | AB | RLD: | No | ||||
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