Details for New Drug Application (NDA): 020401
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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
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
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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