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Details for New Drug Application (NDA): 019734
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NDA 019734 describes CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER profile page.
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. Nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
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. Nine 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: | 4 |
| 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 | Chiesi USA, Inc. | 10122-313 | 10122-313-10 | 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 019734 | NDA | Chiesi USA, Inc. | 10122-313 | 10122-313-10 | 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG |
Paragraph IV (Patent) Challenges for 019734
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| Strength | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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: | Start Trial | Patent Expiration: | Dec 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | 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 | Start Trial | Start Trial |
| Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | Start Trial | Start Trial |
| Chiesi | CARDENE | nicardipine hydrochloride | INJECTABLE;INJECTION | 019734-001 | Jan 30, 1992 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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