Drugs@FDA: FDA-Approved Drugs
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEXITIL | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
MEXITIL | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
MEXITIL | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
12/30/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018873Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/25/2004 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18873slr018ltr.pdf |
12/09/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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09/19/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/21/1991 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
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08/13/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/21/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/22/1989 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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10/21/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/22/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/03/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/10/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1987 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/10/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |