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. Twenty-four 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: | 6 |
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| Strength | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | ⤷ Sign Up | Patent Expiration: | Apr 18, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF |
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 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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