Product Details for ANDA 074377
MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE)
150MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
250MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074377
Product Number: 001
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE)
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074377
Product Number: 001
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074377
Product Number: 002
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE)
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074377
Product Number: 002
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
250MG
Marketing Status: Prescription
Active Ingredient: MEXILETINE HYDROCHLORIDE
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A074377
Product Number: 003
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: MEXILETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A074377
Product Number: 003
Approval Date: May 16, 1995
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information