Details for New Drug Application (NDA): 008306
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NDA 008306 describes PHENERGAN W/ CODEINE, which is a drug marketed by Ani Pharms and is included in one NDA. Additional details are available on the PHENERGAN W/ CODEINE profile page.
The generic ingredient in PHENERGAN W/ CODEINE 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 W/ CODEINE 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 008306
| Tradename: | PHENERGAN W/ CODEINE |
| Applicant: | Ani Pharms |
| Ingredient: | codeine phosphate; promethazine hydrochloride |
| Patents: | 0 |
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 2, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 2, 1984 | TE: | RLD: | Yes | |||||
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