Details for New Drug Application (NDA): 211121
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The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 211121
Tradename: | NICARDIPINE HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211121
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 211121 | ANDA | AuroMedics Pharma LLC | 55150-183 | 55150-183-11 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-11) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-02) |
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 211121 | ANDA | AuroMedics Pharma LLC | 55150-183 | 55150-183-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
Approval Date: | Apr 8, 2021 | TE: | AP | RLD: | No |
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