Details for New Drug Application (NDA): 008604
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NDA 008604 describes PHENERGAN VC, which is a drug marketed by Ani Pharms and is included in two NDAs. Additional details are available on the PHENERGAN VC profile page.
The generic ingredient in PHENERGAN VC is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
The generic ingredient in PHENERGAN VC is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 008604
| Tradename: | PHENERGAN VC |
| Applicant: | Ani Pharms |
| Ingredient: | phenylephrine hydrochloride; promethazine hydrochloride |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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