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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020401

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NDA 020401 describes TIAZAC, which is a drug marketed by Bausch and is included in one NDA. It is available from seven suppliers. Additional details are available on the TIAZAC profile page.

The generic ingredient in TIAZAC is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 020401
Tradename:TIAZAC
Applicant:Bausch
Ingredient:diltiazem hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020401
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 020401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401 NDA Bausch Health Americas, Inc. 0187-2612 0187-2612-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-30)
TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401 NDA Bausch Health Americas, Inc. 0187-2612 0187-2612-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-90)
Paragraph IV (Patent) Challenges for 020401
Tradename Dosage Ingredient NDA Submissiondate
TIAZAC CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020401

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 11, 1995TE:AB4RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Sep 11, 1995TE:AB4RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Sep 11, 1995TE:AB4RLD:Yes

Expired US Patents for NDA 020401

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-006 Oct 16, 1998   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-001 Sep 11, 1995   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-002 Sep 11, 1995   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-003 Sep 11, 1995   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-004 Sep 11, 1995   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-004 Sep 11, 1995   Start Trial   Start Trial
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-005 Sep 11, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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