Details for New Drug Application (NDA): 219608
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NDA 219608 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Senores Pharms, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Somerset Theraps Llc, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-six NDAs. It is available from twenty-five 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 219608
| Tradename: | NICARDIPINE HYDROCHLORIDE |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219608
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 219608 | ANDA | Sagent Pharmaceuticals | 25021-333 | 25021-333-10 | 10 VIAL in 1 CARTON (25021-333-10) / 10 mL in 1 VIAL |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 219608 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0611 | 67184-0611-2 | 10 VIAL in 1 CARTON (67184-0611-2) / 10 mL in 1 VIAL (67184-0611-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
| Approval Date: | Oct 28, 2025 | TE: | AP | RLD: | No | ||||
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