Details for New Drug Application (NDA): 090421
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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 090421
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090421
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 090421
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 090421 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-669 | 47335-669-13 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-13) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 090421 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-669 | 47335-669-18 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Nov 15, 2010 | TE: | AB4 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
Approval Date: | Nov 15, 2010 | TE: | AB4 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Nov 15, 2010 | TE: | AB4 | RLD: | No |
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