Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017569
Company: GLENWOOD
Company: GLENWOOD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENOQUID | SULFACYTINE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/1979 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1978 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1978 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 11/22/1976 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |