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 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 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 | ||||
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 | ||||
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