Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074224
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription AB No No
TRIAZOLAM TRIAZOLAM 0.25MG 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
06/01/1994 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/14/2007 SUPPL-5 Labeling

Label is not available on this site.

12/16/1997 SUPPL-3 Labeling

Label is not available on this site.

08/28/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRIAZOLAM

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCION TRIAZOLAM 0.125MG TABLET;ORAL Prescription Yes AB 017892 PHARMACIA AND UPJOHN
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 074224 HIKMA
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 074031 MYLAN PHARMS INC

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCION TRIAZOLAM 0.25MG TABLET;ORAL Prescription Yes AB 017892 PHARMACIA AND UPJOHN
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074224 HIKMA
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074031 MYLAN PHARMS INC

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