Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205811
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;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
08/19/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205811Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205811Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/19/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205811Orig1s000lbl.pdf

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

TABLET, DELAYED RELEASE;ORAL; 10MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLEGIS DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 021876 DUCHESNAY
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 205811 ACTAVIS LABS FL INC
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 208518 PAR PHARM INC

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