Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204229
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription AB No No
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL 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
09/11/2017 ORIG-1 Approval

Label is not available on this site.

ZOLPIDEM TARTRATE

TABLET;SUBLINGUAL; 1.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTERMEZZO ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription Yes AB 022328 PURDUE PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription No AB 204503 DR REDDYS LABS INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription No AB 204299 NOVEL LABS INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription No AB 204229 PAR PHARM INC

TABLET;SUBLINGUAL; 3.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTERMEZZO ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Prescription Yes AB 022328 PURDUE PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Prescription No AB 204503 DR REDDYS LABS INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Prescription No AB 204299 NOVEL LABS INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Prescription No AB 204229 PAR PHARM INC

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