Details for New Drug Application (NDA): 018602
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The generic ingredient in CARDIZEM 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 018602
Tradename: | CARDIZEM |
Applicant: | Bausch |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 018602
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 018602
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602 | NDA | Bausch Health US LLC | 0187-0771 | 0187-0771-47 | 100 TABLET, COATED in 1 BOTTLE (0187-0771-47) |
CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602 | NDA | Bausch Health US LLC | 0187-0772 | 0187-0772-47 | 100 TABLET, COATED in 1 BOTTLE (0187-0772-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Nov 5, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Nov 5, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Dec 8, 1986 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 018602
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-001 | Nov 5, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-004 | Dec 8, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-004 | Dec 8, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-004 | Dec 8, 1986 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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