Product Details for NDA 018873
MEXITIL (MEXILETINE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 002
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information
MEXITIL (MEXILETINE HYDROCHLORIDE)
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 002
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 003
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information
MEXITIL (MEXILETINE HYDROCHLORIDE)
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 003
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 004
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MEXITIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018873
Product Number: 004
Approval Date: Dec 30, 1985
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status: Discontinued
Patent and Exclusivity Information