Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202191

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METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: METOCLOPRAMIDE HYDROCHLORIDE
Proprietary Name: METOCLOPRAMIDE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202191
Product Number: 001
Approval Date: Aug 15, 2014
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: METOCLOPRAMIDE HYDROCHLORIDE
Proprietary Name: METOCLOPRAMIDE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A202191
Product Number: 002
Approval Date: Aug 15, 2014
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information