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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Dow
Chinese Patent Office
Merck
Colorcon
Citi
Express Scripts
Fuji
Queensland Health

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075116

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NDA 075116 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-seven 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 075116
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Valeant Pharms North
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075116
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 075116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075116 ANDA Teva Pharmaceuticals USA Inc. 0093-5112 N 0093-5112-98
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075116 ANDA Teva Pharmaceuticals USA Inc. 0093-5117 N 0093-5117-98

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Dec 23, 1999TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Dec 23, 1999TE:AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Dec 23, 1999TE:AB3RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Baxter
Federal Trade Commission
Express Scripts
Mallinckrodt
Cantor Fitzgerald
Johnson and Johnson
Harvard Business School
Moodys

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