Details for New Drug Application (NDA): 019734
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The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 019734
Tradename: | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER |
Applicant: | Chiesi |
Ingredient: | nicardipine hydrochloride |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019734
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734 | NDA | Baxter Healthcare Corporation | 43066-009 | 43066-009-10 | 10 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG |
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 019734 | NDA | Baxter Healthcare Corporation | 43066-009 | 43066-009-10 | 10 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 30, 1992 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
Approval Date: | Jul 31, 2008 | TE: | RLD: | Yes | |||||
Patent: | See Plans and Pricing | Patent Expiration: | Apr 18, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 019734
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | See Plans and Pricing | See Plans and Pricing |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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