Details for New Drug Application (NDA): 216420
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NDA 216420 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan, Senores Pharms, Am Regent, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, and Wockhardt, and is included in seventeen NDAs. It is available from fifteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 216420
| Tradename: | NICARDIPINE HYDROCHLORIDE |
| Applicant: | Micro Labs |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216420
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 216420 | ANDA | Micro Labs Limited | 42571-394 | 42571-394-89 | 10 VIAL in 1 CARTON (42571-394-89) / 10 mL in 1 VIAL (42571-394-88) |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 216420 | ANDA | Armas Pharmaceuticals Inc. | 72485-116 | 72485-116-10 | 10 VIAL in 1 CARTON (72485-116-10) / 10 mL in 1 VIAL (72485-116-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
| Approval Date: | Jul 7, 2023 | TE: | AP | RLD: | No | ||||
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