Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040089
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/28/1995 | 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 |
---|---|---|---|---|---|
01/25/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
10/27/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/06/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202693 | AVET LIFESCIENCES |
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040089 | HIKMA |
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200880 | MYLAN ASI |
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040784 | XGEN PHARMS |
ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206533 | ZYDUS PHARMS |