Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040062
Company: MIKART
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | 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 |
---|---|---|---|---|---|---|---|
01/27/1994 | 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 |
---|---|---|---|---|---|
08/13/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/31/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/08/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METHAZOLAMIDE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040001 | ANI PHARMS |
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 207438 | BAUSCH AND LOMB INC |
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040062 | MIKART |
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040036 | SANDOZ |
METHAZOLAMIDE | METHAZOLAMIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 215615 | TAGI |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040001 | ANI PHARMS |
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 207438 | BAUSCH AND LOMB INC |
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040062 | MIKART |
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040036 | SANDOZ |
METHAZOLAMIDE | METHAZOLAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 215615 | TAGI |