Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205661
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | 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 |
---|---|---|---|---|---|---|---|
07/05/2016 | 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 |
---|---|---|---|---|---|
05/15/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
05/15/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
METHENAMINE HIPPURATE
TABLET;ORAL; 1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HIPREX | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | Yes | AB | 017681 | SS PHARMA |
METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | No | AB | 205661 | AUROBINDO PHARMA LTD |
METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | No | AB | 217675 | JUBILANT CADISTA |
METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | No | AB | 212172 | MICRO LABS |
METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | No | AB | 210068 | NOVAST LABS |
UREX | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | No | AB | 016151 | ALVOGEN |