Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204299
Company: NOVEL LABS 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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/03/2015 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
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Prescription No AB 204503 DR REDDYS
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
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Prescription No AB 204503 DR REDDYS
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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