Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070983
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/06/1987 | 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 |
---|---|---|---|---|---|
02/23/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/03/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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11/19/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/19/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |