Details for New Drug Application (NDA): 020152
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The generic ingredient in SERZONE is nefazodone hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.
Summary for 020152
| Tradename: | SERZONE |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | nefazodone hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 22, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 22, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 22, 1994 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020152
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SERZONE | nefazodone hydrochloride | TABLET;ORAL | 020152-005 | Dec 22, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bristol Myers Squibb | SERZONE | nefazodone hydrochloride | TABLET;ORAL | 020152-003 | Dec 22, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bristol Myers Squibb | SERZONE | nefazodone hydrochloride | TABLET;ORAL | 020152-005 | Dec 22, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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