Details for New Drug Application (NDA): 022276
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The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 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 022276
Tradename: | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
Applicant: | Hikma Intl Pharms |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022276
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 022276 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9542 | 0143-9542-10 | 10 VIAL in 1 CARTON (0143-9542-10) / 10 mL in 1 VIAL (0143-9542-01) |
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 022276 | NDA | West-Ward Pharmaceuticals Corp | 0143-9593 | 0143-9593-10 | 10 VIAL in 1 CARTON (0143-9593-10) / 10 mL in 1 VIAL (0143-9593-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
Approval Date: | Jul 24, 2008 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
Approval Date: | Apr 7, 2016 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40MG/200ML (0.2MG/ML) | ||||
Approval Date: | Apr 7, 2016 | TE: | RLD: | Yes |
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