Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | 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 |
---|---|---|---|---|---|---|---|
08/15/1988 | 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 |
---|---|---|---|---|---|
12/20/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
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08/07/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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08/19/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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04/06/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/16/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |