Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205301
Company: CADILA
Company: CADILA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
01/16/2019 | 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 |
---|---|---|---|---|---|
09/14/2023 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207659 | ACCORD HLTHCARE |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210423 | ALEMBIC |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205301 | CADILA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040904 | HERITAGE PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090779 | INDICUS PHARMA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207401 | MICRO LABS LTD INDIA |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204691 | NOSTRUM LABS INC |
ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203434 | NOVAST LABS |