Details for New Drug Application (NDA): 218426
NDA 218426 describes DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, which is a drug marketed by Actavis Elizabeth, Hetero Labs Ltd Iii, and Sun Pharm, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE profile page.
The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.
The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.
Summary for 218426
| Tradename: | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | dextromethorphan hydrobromide; quinidine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218426
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 218426 | ANDA | Camber Pharmaceuticals, Inc. | 31722-693 | 31722-693-60 | 60 CAPSULE in 1 BOTTLE (31722-693-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;10MG | ||||
| Approval Date: | Aug 28, 2024 | TE: | AB | RLD: | No | ||||
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