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Generated: March 22, 2019

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Details for New Drug Application (NDA): 078538

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NDA 078538 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Mylan, Nesher Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Sun Pharma Global, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms Usa Inc, Akorn Inc, Athenex Inc, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, and Teva Pharms, and is included in thirty-eight NDAs. It is available from thirty-nine 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-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 078538
Applicant:West-ward Pharms Int
Ingredient:diltiazem hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 078538
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 078538
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 078538 ANDA West-Ward Pharmaceuticals Corp. 0641-6013 0641-6013-10 10 VIAL in 1 CARTON (0641-6013-10) > 5 mL in 1 VIAL (0641-6013-01)
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 078538 ANDA West-Ward Pharmaceuticals Corp. 0641-6014 0641-6014-10 10 VIAL in 1 CARTON (0641-6014-10) > 10 mL in 1 VIAL (0641-6014-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Dec 17, 2008TE:APRLD:No

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