Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018873
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.

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.

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.

10/21/1991 SUPPL-10 Labeling

Label is not available on this site.

10/21/1991 SUPPL-9 Labeling

Label is not available on this site.

03/22/1989 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/21/1991 SUPPL-7 Labeling

Label is not available on this site.

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.

09/10/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1987 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/10/1987 SUPPL-2 Labeling

Label is not available on this site.

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