Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074970
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74970ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/12/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |