Details for New Drug Application (NDA): 020062
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NDA 020062 describes CARDIZEM CD, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the CARDIZEM CD profile page.
The generic ingredient in CARDIZEM CD 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.
The generic ingredient in CARDIZEM CD 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 020062
| Tradename: | CARDIZEM CD |
| Applicant: | Bausch |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020062
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 020062
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062 | NDA | Bausch Health US LLC | 0187-0795 | 0187-0795-30 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) |
| CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062 | NDA | Bausch Health US LLC | 0187-0795 | 0187-0795-42 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Aug 10, 1992 | TE: | AB3 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Dec 27, 1991 | TE: | AB3 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Dec 27, 1991 | TE: | AB3 | RLD: | Yes | ||||
Expired US Patents for NDA 020062
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-003 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-003 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-002 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-001 | Aug 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-005 | Aug 24, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-004 | Dec 27, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-001 | Aug 10, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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