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Details for New Drug Application (NDA): 020401

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NDA 020401 describes TIAZAC, which is a drug marketed by Valeant Pharms North 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. Forty-one suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for NDA: 020401

Tradename:
TIAZAC
Applicant:
Valeant Pharms North
Ingredient:
diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
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 Valeant Pharmaceuticals North America 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 Valeant Pharmaceuticals North America LLC 0187-2612 0187-2612-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2612-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 11, 1995TE:AB4RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Sep 11, 1995TE:AB4RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Sep 11, 1995TE:AB4RLD:No

Expired Orange Book Patents for NDA: 020401

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-001Sep 11, 19955,529,791► subscribe
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-004Sep 11, 19955,529,791► subscribe
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-006Oct 16, 19985,529,791► subscribe
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