Details for New Drug Application (NDA): 200894
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NDA 200894 describes PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 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 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 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 200894
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
| Applicant: | Amneal Pharms |
| Ingredient: | codeine phosphate; promethazine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Apr 24, 2013 | TE: | AA | RLD: | No | ||||
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