Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: August 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204238

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NDA 204238 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, Natco Pharma, Orchid Hlthcare, Taro Pharm, and Teva Pharms, and is included in forty-four NDAs. It is available from sixteen suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 204238
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:granisetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204238
Suppliers and Packaging for NDA: 204238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 204238 ANDA AuroMedics Pharma LLC 55150-175 55150-175-01 1 VIAL, SINGLE-USE in 1 CARTON (55150-175-01) > 1 mL in 1 VIAL, SINGLE-USE
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 204238 ANDA AuroMedics Pharma LLC 55150-176 55150-176-04 1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) > 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Jul 6, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Jul 6, 2016TE:APRLD:No

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