Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091136

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GRANISETRON HYDROCHLORIDE (GRANISETRON HYDROCHLORIDE)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: GRANISETRON HYDROCHLORIDE
Proprietary Name: GRANISETRON HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A091136
Product Number: 001
Approval Date: Apr 9, 2010
Applicant Holder Full Name: MYLAN ASI LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

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: AP
Application Number: A091136
Product Number: 002
Approval Date: Apr 9, 2010
Applicant Holder Full Name: MYLAN ASI LLC
Marketing Status:  Prescription
Patent and Exclusivity Information