Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075052
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
| 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 |
|---|---|---|---|---|---|---|---|
| 06/18/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75052ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/30/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/20/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/14/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |