Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013636
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENESE-R | POLYTHIAZIDE; RESERPINE | 2MG;0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/1963 | 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 |
|---|---|---|---|---|---|
| 06/26/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/09/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/13/1981 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/22/1975 | SUPPL-7 | Labeling |
Label is not available on this site. |