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 four 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-two 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

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

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:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Sep 11, 1995	TE:	AB4	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Sep 11, 1995	TE:	AB4	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Sep 11, 1995	TE:	AB4	RLD:	Yes

Expired US Patents for NDA 020401

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020401-006	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	020401-006	Oct 16, 1998	⤷ 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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