Details for New Drug Application (NDA): 219334
NDA 219334 describes NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Caplin, Cipla, Fresenius Kabi Usa, and Hikma Intl Pharms, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is nicardipine hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is nicardipine hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 219334
| Tradename: | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219334
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 219334 | ANDA | Fresenius Kabi USA, LLC | 65219-296 | 65219-296-20 | 10 BAG in 1 CASE (65219-296-20) / 200 mL in 1 BAG (65219-296-01) |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 219334 | ANDA | Fresenius Kabi USA, LLC | 65219-298 | 65219-298-20 | 10 BAG in 1 CASE (65219-298-20) / 200 mL in 1 BAG (65219-298-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
| Approval Date: | Aug 4, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40MG/200ML (0.2MG/ML) | ||||
| Approval Date: | Aug 4, 2026 | TE: | AP | RLD: | No | ||||
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