Details for New Drug Application (NDA): 215377
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The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Nineteen 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 |
Formulation / Manufacturing: | see details |
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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