Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070347
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRO-RIDE | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/06/1986 | 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 |
|---|---|---|---|---|---|
| 05/13/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/13/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/24/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/28/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/05/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/10/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/27/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |