Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202934
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/10/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202934Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/24/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
CAPSULE;ORAL; 20MG;10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL | Prescription | No | AB | 202934 | ACTAVIS ELIZABETH |
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL | Prescription | No | AB | 218426 | HETERO LABS LTD III |
NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021879 | AVANIR PHARMS |