Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OCUSERT PILO-20 | PILOCARPINE | 5MG | INSERT, EXTENDED RELEASE;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1974 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 01/20/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/13/1993 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1992 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/02/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 10/18/1990 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/18/1990 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/24/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/09/1989 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/11/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1987 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/04/1983 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/24/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 11/19/1980 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/17/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/29/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/14/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/30/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/11/1977 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/01/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/21/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/29/1974 | SUPPL-1 |
Label is not available on this site. |