Details for New Drug Application (NDA): 215377
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NDA 215377 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, Inforlife, and Cipla, and is included in twenty-one NDAs. It is available from twenty-two 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. Twenty-four 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. Twenty-four suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 215377
| Tradename: | NICARDIPINE HYDROCHLORIDE |
| Applicant: | Senores Pharms |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215377
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 215377 | ANDA | Burel Pharmaceuticals, LLC | 35573-457 | 35573-457-85 | 90 CAPSULE in 1 BOTTLE (35573-457-85) |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 215377 | ANDA | Burel Pharmaceuticals, LLC | 35573-458 | 35573-458-85 | 90 CAPSULE in 1 BOTTLE (35573-458-85) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 17, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jul 17, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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