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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090492

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NDA 090492 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 forty 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-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 090492
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Sun Pharma Global
Ingredient:diltiazem hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090492
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 090492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492 ANDA Sun Pharmaceutical Industries, Inc. 47335-675 47335-675-13 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-13)
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492 ANDA Sun Pharmaceutical Industries, Inc. 47335-675 47335-675-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

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