Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS UT INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOXITANE IM | LOXAPINE HYDROCHLORIDE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
10/26/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
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-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf | |
09/16/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/21/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/29/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/20/1984 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/10/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/17/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/08/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/20/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/06/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/16/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/23/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf |