Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078939

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ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: ETHAMBUTOL HYDROCHLORIDE
Proprietary Name: ETHAMBUTOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078939
Product Number: 001
Approval Date: Jun 17, 2009
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
400MG
Marketing Status: Prescription

Active Ingredient: ETHAMBUTOL HYDROCHLORIDE
Proprietary Name: ETHAMBUTOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078939
Product Number: 002
Approval Date: Jun 17, 2009
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information