Details for New Drug Application (NDA): 074752
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The generic ingredient in CARTIA XT is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074752
Tradename: | CARTIA XT |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074752
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 074752
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARTIA XT | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074752 | ANDA | Actavis Pharma, Inc. | 62037-597 | 62037-597-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-05) |
CARTIA XT | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074752 | ANDA | Actavis Pharma, Inc. | 62037-597 | 62037-597-90 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
Approval Date: | Jul 9, 1998 | TE: | AB3 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Jul 9, 1998 | TE: | AB3 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Jul 9, 1998 | TE: | AB3 | RLD: | No |
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