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Generated: December 11, 2017

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, 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-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 090492

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
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 Pharma Global FZE 47335-675 47335-675-19 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-19)
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492 ANDA Sun Pharma Global FZE 47335-675 47335-675-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-675-83)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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McKesson
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