Details for New Drug Application (NDA): 022276
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NDA 022276 describes NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Cipla and Hikma Intl Pharms and is included in two NDAs. It is available from four suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 022276
| Tradename: | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 022276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 022276 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9542 | 0143-9542-10 | 10 VIAL in 1 CARTON (0143-9542-10) / 10 mL in 1 VIAL (0143-9542-01) |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 022276 | NDA | West-Ward Pharmaceuticals Corp | 0143-9593 | 0143-9593-10 | 10 VIAL in 1 CARTON (0143-9593-10) / 10 mL in 1 VIAL (0143-9593-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
| Approval Date: | Jul 24, 2008 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
| Approval Date: | Apr 7, 2016 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40MG/200ML (0.2MG/ML) | ||||
| Approval Date: | Apr 7, 2016 | TE: | AP | RLD: | Yes | ||||
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