Details for New Drug Application (NDA): 074984
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The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074984
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Par Pharm |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074984
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 074984
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074984 | ANDA | Par Pharmaceutical, Inc. | 10370-829 | 10370-829-05 | 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-05) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074984 | ANDA | Par Pharmaceutical, Inc. | 10370-829 | 10370-829-09 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Dec 20, 1999 | TE: | AB3 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
Approval Date: | Dec 20, 1999 | TE: | AB3 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Dec 20, 1999 | TE: | AB3 | RLD: | No |
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