Details for New Drug Application (NDA): 088762
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NDA 088762 describes PROMETH W/ DEXTROMETHORPHAN, which is a drug marketed by G And W Labs Inc and is included in one NDA. Additional details are available on the PROMETH W/ DEXTROMETHORPHAN profile page.
The generic ingredient in PROMETH W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
The generic ingredient in PROMETH W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 088762
| Tradename: | PROMETH W/ DEXTROMETHORPHAN |
| Applicant: | G And W Labs Inc |
| Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 31, 1984 | TE: | RLD: | No | |||||
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