Details for New Drug Application (NDA): 211596
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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-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 211596
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Edenbridge Pharms |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211596
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 211596
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 211596 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-129 | 42799-129-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42799-129-01) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 211596 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-129 | 42799-129-02 | 500 TABLET, FILM COATED in 1 BOTTLE (42799-129-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Nov 18, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Nov 18, 2019 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Nov 18, 2019 | TE: | RLD: | No |
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