Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018873
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEXITIL | MEXILETINE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| MEXITIL | MEXILETINE HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| MEXITIL | MEXILETINE HYDROCHLORIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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. |
||
| 09/30/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 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. |
||
| 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. |
||
| 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. |