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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202934
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
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