Details for New Drug Application (NDA): 217548
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The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 217548
Tradename: | NICARDIPINE HYDROCHLORIDE |
Applicant: | Chengdu Shuode |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 217548
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 217548 | ANDA | Fresenius Kabi USA, LLC | 65219-818 | 65219-818-10 | 1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS |
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 217548 | ANDA | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-103 | 82432-103-01 | 1 VIAL, GLASS in 1 CARTON (82432-103-01) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
Approval Date: | Sep 6, 2024 | TE: | AP | RLD: | No |
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