Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013428
Company: ENDO PHARMS
Company: ENDO PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALPIN 50 | ANISOTROPINE METHYLBROMIDE | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/1962 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 07/02/1986 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/23/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/1978 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/21/1978 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-21 | Efficacy |
Label is not available on this site. |