Details for New Drug Application (NDA): 218426
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NDA 218426 describes DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, which is a drug marketed by Actavis Elizabeth and Hetero Labs Ltd Iii and is included in two NDAs. It is available from one supplier. 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 are twenty-three drug master file entries for this compound. Three 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 are twenty-three drug master file entries for this compound. Three 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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