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Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091022

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NDA 091022 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: 091022

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

Pharmacology for NDA: 091022

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 091022

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 091022 ANDA Sandoz Inc 0781-2452 0781-2452-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2452-05)
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 091022 ANDA Sandoz Inc 0781-2452 0781-2452-31 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2452-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 28, 2012TE:AB4RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Sep 28, 2012TE:AB4RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Sep 28, 2012TE:AB4RLD:No


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