Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204238

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GRANISETRON HYDROCHLORIDE (GRANISETRON HYDROCHLORIDE)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: GRANISETRON HYDROCHLORIDE
Proprietary Name: GRANISETRON HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204238
Product Number: 001
Approval Date: Jul 6, 2016
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

GRANISETRON HYDROCHLORIDE (GRANISETRON HYDROCHLORIDE)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: GRANISETRON HYDROCHLORIDE
Proprietary Name: GRANISETRON HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204238
Product Number: 002
Approval Date: Jul 6, 2016
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information