Details for New Drug Application (NDA): 021392
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NDA 021392 describes CARDIZEM LA, 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 LA profile page.
The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 021392
| Tradename: | CARDIZEM LA |
| Applicant: | Bausch |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021392
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 021392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392 | NDA | Bausch Health US LLC | 0187-2045 | 0187-2045-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30) |
| CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392 | NDA | Bausch Health US LLC | 0187-2045 | 0187-2045-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Feb 6, 2003 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Feb 6, 2003 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Feb 6, 2003 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021392
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-005 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-005 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-002 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-004 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-003 | Feb 6, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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