Details for New Drug Application (NDA): 088864
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NDA 088864 describes PROMETHAZINE W/ DEXTROMETHORPHAN, which is a drug marketed by Pharmobedient and is included in one NDA. It is available from three suppliers. Additional details are available on the PROMETHAZINE W/ DEXTROMETHORPHAN profile page.
The generic ingredient in PROMETHAZINE W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 088864
| Tradename: | PROMETHAZINE W/ DEXTROMETHORPHAN |
| Applicant: | Pharmobedient |
| Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 088864
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 088864
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE W/ DEXTROMETHORPHAN | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 088864 | ANDA | Xttrium Laboratories, Inc | 0116-4024 | 0116-4024-16 | 473 mL in 1 BOTTLE, PLASTIC (0116-4024-16) |
| PROMETHAZINE W/ DEXTROMETHORPHAN | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 088864 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0604 | 17856-0604-4 | 72 CUP in 1 BOX (17856-0604-4) / 5 mL in 1 CUP (17856-0604-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Jan 4, 1985 | TE: | AA | RLD: | No | ||||
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