Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040195
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | AB | No | No |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/28/1997 | 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 |
---|---|---|---|---|---|
01/09/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
ACETAZOLAMIDE
TABLET;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 211372 | APPCO |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 218023 | EPIC PHARMA LLC |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 205530 | HERITAGE PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 214282 | MANKIND PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 217197 | NE RX PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 210588 | NOVITIUM PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 215101 | RUBICON |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 209734 | STRIDES PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 040195 | TARO |
ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 211069 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211372 | APPCO |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 084840 | CHARTWELL MOLECULAR |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 218023 | EPIC PHARMA LLC |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 205530 | HERITAGE PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 214282 | MANKIND PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 217197 | NE RX PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 210588 | NOVITIUM PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 215101 | RUBICON |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 209734 | STRIDES PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 040195 | TARO |
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211069 | ZYDUS LIFESCIENCES |