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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 212965


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NDA 212965 describes VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Mylan, Rising, Abraxis Pharm, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Hospira, Intl Medication, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Caplin, Exela Pharma, Micro Labs, Nephron, Somerset, Somerset Theraps Llc, Apotex Corp, Cadila Pharms Ltd, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Pliva, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Chartwell Rx, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in sixty-five NDAs. It is available from forty-three suppliers. Additional details are available on the VERAPAMIL HYDROCHLORIDE profile page.

The generic ingredient in VERAPAMIL HYDROCHLORIDE is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.
Summary for 212965
Tradename:VERAPAMIL HYDROCHLORIDE
Applicant:Eugia Pharma
Ingredient:verapamil hydrochloride
Patents:0
Suppliers and Packaging for NDA: 212965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERAPAMIL HYDROCHLORIDE verapamil hydrochloride INJECTABLE;INJECTION 212965 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1548 51662-1548-1 4 mL in 1 VIAL, SINGLE-DOSE (51662-1548-1)
VERAPAMIL HYDROCHLORIDE verapamil hydrochloride INJECTABLE;INJECTION 212965 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1549 51662-1549-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1549-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5MG/ML
Approval Date:Jul 6, 2020TE:APRLD:No

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