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Last Updated: November 21, 2024

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 five 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. Fifty-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
Pharmacology for NDA: 020401
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 US, LLC 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 US, LLC 0187-2612 0187-2612-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-90)

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 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-001 Sep 11, 1995 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-002 Sep 11, 1995 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-003 Sep 11, 1995 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-004 Sep 11, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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