U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213003
Company: ZYDUS PHARMS
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
12/28/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2023 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

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 214219 NOVAST LABS
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 216890 SANDOZ
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 213003 ZYDUS PHARMS

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 214219 NOVAST LABS
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 216890 SANDOZ
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 213003 ZYDUS PHARMS
Back to Top