Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091667
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription AB No No
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;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
07/25/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

MISOPROSTOL

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.1MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.2MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

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