Details for New Drug Application (NDA): 075116
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The generic ingredient in DILTIAZEM HYDROCHLORIDE 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 075116
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Valeant Pharms North |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 075116
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 075116
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075116 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-4005 | 68071-4005-3 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-3) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075116 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-4005 | 68071-4005-9 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Dec 23, 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 23, 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 23, 1999 | TE: | AB3 | RLD: | No |
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