Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062635
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 01/08/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/08/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/15/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/07/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 09/30/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/30/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |