Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016151
Company: ALVOGEN
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UREX | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/05/1967 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 03/30/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016151s025ltr.pdf | |
| 07/02/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/21/1986 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/06/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/24/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/11/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf |
UREX
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 |