Details for New Drug Application (NDA): 220869
NDA 220869 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Cosette Pharms Nc, Hetero Labs Ltd Iii, Hikma, and Rubicon Research, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There is one drug master file entry 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 HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 220869
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
| Applicant: | Rubicon Research |
| Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 220869
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 220869
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 220869 | ANDA | Advagen Pharma Ltd | 72888-038 | 72888-038-01 | 473 mL in 1 BOTTLE (72888-038-01) |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 220869 | ANDA | Advagen Pharma Ltd | 72888-038 | 72888-038-02 | 118 mL in 1 BOTTLE (72888-038-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Jun 23, 2026 | TE: | AA | RLD: | No | ||||
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