Product Details for ANDA 201451
MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
12.5MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
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: Yes
TE Code: AA
Application Number: A201451
Product Number: 001
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information
MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A201451
Product Number: 001
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: Yes
TE Code: AA
Application Number: A201451
Product Number: 002
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information
MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A201451
Product Number: 002
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A201451
Product Number: 003
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A201451
Product Number: 003
Approval Date: Feb 23, 2011
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status: Prescription
Patent and Exclusivity Information