Details for New Drug Application (NDA): 202463
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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 202463
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Actavis Elizabeth |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202463
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 202463
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 202463 | ANDA | Actavis Pharma, Inc. | 0228-2918 | 0228-2918-09 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2918-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 360MG | ||||
Approval Date: | Dec 7, 2012 | TE: | AB3 | RLD: | No |
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