Details for New Drug Application (NDA): 090534
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NDA 090534 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Anda Repository, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Rk Pharma, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-six NDAs. It is available from twenty-one suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 090534
| Tradename: | NICARDIPINE HYDROCHLORIDE |
| Applicant: | Am Regent |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090534
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 090534 | ANDA | American Regent, Inc. | 0517-0735 | 0517-0735-10 | 10 VIAL in 1 CARTON (0517-0735-10) / 10 mL in 1 VIAL (0517-0735-01) |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 090534 | ANDA | Civica, Inc. | 72572-470 | 72572-470-10 | 10 VIAL in 1 CARTON (72572-470-10) / 10 mL in 1 VIAL (72572-470-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
| Approval Date: | Nov 17, 2009 | TE: | AP | RLD: | No | ||||
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