Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214219
Company: NOVAST LABS
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
10/20/2020 ORIG-1 Approval STANDARD

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 PFIZER
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 074224 HIKMA PHARMS
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 214219 NOVAST LABS

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 PFIZER
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074224 HIKMA PHARMS
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 214219 NOVAST LABS

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