Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011971
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORETIC | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| ORETIC | HYDROCHLOROTHIAZIDE | 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 |
|---|---|---|---|---|---|---|---|
| 07/06/1959 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 04/16/1998 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/15/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/13/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/03/1975 | SUPPL-12 | Labeling |
Label is not available on this site. |