Drugs@FDA: FDA-Approved Drugs
Company: PARKEDALE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIRA-A | VIDARABINE | 3% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
11/26/1976 | 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 |
---|---|---|---|---|---|
07/26/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/28/1998 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/04/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/04/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
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08/27/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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12/12/1977 | SUPPL-12 | Labeling |
Label is not available on this site. |
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08/04/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/29/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/22/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/20/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/05/1978 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/15/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/01/1977 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1976 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |