Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POLY-PRED | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE | EQ 0.35% BASE;10,000 UNITS/ML;0.5% | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
05/10/1963 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/19/2003 | SUPPL-38 | Labeling |
Label is not available on this site. |
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04/12/2002 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/21/2002 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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04/12/2001 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/1998 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/02/1982 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/30/1981 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/18/1980 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/16/1979 | SUPPL-24 | Labeling |
Label is not available on this site. |
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12/02/1965 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
08/03/1995 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/07/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/17/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/23/1964 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/12/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/04/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/23/1963 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/10/1984 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
11/01/1985 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/18/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/15/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/26/1982 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |