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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074941

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NDA 074941 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Hospira, Mylan, Valeant Pharms North, Athenex Inc, Sun Pharma Global, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, West-ward Pharms Int, Biovail, Apotex, Intl Medication, Hikma Farmaceutica, Apothecon, Actavis Labs Fl Inc, Actavis Elizabeth, Nesher Pharms, Teva Pharms, Ivax Sub Teva Pharms, Mylan Labs Ltd, Teva, Par Pharm, Akorn Inc, Chartwell Molecules, and Teva Pharms Usa, and is included in thirty-six NDAs. It is available from forty-three suppliers. Additional details are available on the DILTIAZEM HYDROCHLORIDE profile page.

The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for NDA: 074941

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074941

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 074941

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
INJECTABLE;INJECTION 074941 ANDA Hospira, Inc. 0409-1171 0409-1171-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-01) > 5 mL in 1 VIAL, SINGLE-DOSE
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
INJECTABLE;INJECTION 074941 ANDA Hospira, Inc. 0409-1171 0409-1171-02 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-02) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Apr 15, 1998TE:APRLD:No


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