Details for New Drug Application (NDA): 010926
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NDA 010926 describes PHENERGAN, which is a drug marketed by Wyeth Ayerst, Norvium Bioscience, Delcor Asset Corp, and Ani Pharms, and is included in six NDAs. Additional details are available on the PHENERGAN profile page.
The generic ingredient in PHENERGAN is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
The generic ingredient in PHENERGAN is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 010926
| Tradename: | PHENERGAN |
| Applicant: | Norvium Bioscience |
| Ingredient: | promethazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 010926
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUPPOSITORY;RECTAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUPPOSITORY;RECTAL | Strength | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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