Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213003
Company: ZYDUS PHARMS
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 |