Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012148
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORETICYL 25 | DESERPIDINE; HYDROCHLOROTHIAZIDE | 0.125MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
| ORETICYL 50 | DESERPIDINE; HYDROCHLOROTHIAZIDE | 0.125MG;50MG | TABLET;ORAL | Discontinued | None | No | No |
| ORETICYL FORTE | DESERPIDINE; HYDROCHLOROTHIAZIDE | 0.25MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/14/1959 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 02/16/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 02/16/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 02/08/1984 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/16/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/20/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 08/20/1979 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/17/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |