Details for New Drug Application (NDA): 076037
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NDA 076037 describes NEFAZODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Roxane, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in nine NDAs. It is available from one supplier. Additional details are available on the NEFAZODONE HYDROCHLORIDE profile page.
The generic ingredient in NEFAZODONE HYDROCHLORIDE is nefazodone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.
The generic ingredient in NEFAZODONE HYDROCHLORIDE is nefazodone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.
Summary for 076037
| Tradename: | NEFAZODONE HYDROCHLORIDE |
| Applicant: | Teva |
| Ingredient: | nefazodone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076037
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEFAZODONE HYDROCHLORIDE | nefazodone hydrochloride | TABLET;ORAL | 076037 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1024 | 0093-1024-06 | 60 TABLET in 1 BOTTLE (0093-1024-06) |
| NEFAZODONE HYDROCHLORIDE | nefazodone hydrochloride | TABLET;ORAL | 076037 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1025 | 0093-1025-06 | 60 TABLET in 1 BOTTLE (0093-1025-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 16, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 16, 2003 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 16, 2003 | TE: | RLD: | No | |||||
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