Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202640

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MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
12.5MG
Marketing Status: Prescription

Active Ingredient: MECLIZINE HYDROCHLORIDE
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202640
Product Number: 001
Approval Date: Sep 17, 2012
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription

Active Ingredient: MECLIZINE HYDROCHLORIDE
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202640
Product Number: 002
Approval Date: Sep 17, 2012
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
50MG
Marketing Status: Prescription

Active Ingredient: MECLIZINE HYDROCHLORIDE
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202640
Product Number: 003
Approval Date: Sep 17, 2012
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information