Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011657
Company: FOREST LABS
Company: FOREST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAPRONE | PROPIOLACTONE | N/A | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/26/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/26/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/08/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/16/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 11/09/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/09/1976 | SUPPL-6 | Labeling |
Label is not available on this site. |