Details for New Drug Application (NDA): 203978
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NDA 203978 describes NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE, which is a drug marketed by Inforlife and is included in one NDA. It is available from one supplier. Additional details are available on the NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 203978
| Tradename: | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE |
| Applicant: | Inforlife |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203978
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 203978 | ANDA | WG Critical Care, LLC | 44567-850 | 44567-850-12 | 12 BAG in 1 CARTON (44567-850-12) / 200 mL in 1 BAG (44567-850-01) |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 203978 | ANDA | WG Critical Care, LLC | 44567-851 | 44567-851-12 | 12 BAG in 1 CARTON (44567-851-12) / 200 mL in 1 BAG (44567-851-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
| Approval Date: | Apr 17, 2024 | 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: | Apr 17, 2024 | TE: | AP | RLD: | No | ||||
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