Details for New Drug Application (NDA): 216552
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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 216552
Tradename: | DILTIAZEM HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216552
Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 216552
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 216552 | ANDA | Eugia US LLC | 55150-425 | 55150-425-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-425-10) / 5 mL in 1 VIAL, SINGLE-DOSE (55150-425-01) |
DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 216552 | ANDA | Eugia US LLC | 55150-426 | 55150-426-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-426-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-426-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Mar 29, 2023 | TE: | AP | RLD: | No |
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