Details for New Drug Application (NDA): 215592
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NDA 215592 describes NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Caplin, Cipla, and Hikma Intl Pharms, and is included in three NDAs. It is available from five 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-six 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-six suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 215592
| Tradename: | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Cipla |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 215592 | ANDA | Cipla USA Inc. | 69097-007 | 69097-007-22 | 10 BAG in 1 CARTON (69097-007-22) / 200 mL in 1 BAG (69097-007-45) |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | nicardipine hydrochloride | INJECTABLE;INTRAVENOUS | 215592 | ANDA | Cipla USA Inc. | 69097-008 | 69097-008-22 | 10 BAG in 1 CARTON (69097-008-22) / 200 mL in 1 BAG (69097-008-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 20MG/200ML (0.1MG/ML) | ||||
| Approval Date: | Sep 24, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | May 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 40MG/200ML (0.2MG/ML) | ||||
| Approval Date: | Sep 24, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | May 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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