Details for New Drug Application (NDA): 218202
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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 218202
Tradename: | NICARDIPINE HYDROCHLORIDE |
Applicant: | Skg Pharma |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 218202
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 218202 | ANDA | SKG Pharma Inc. | 83085-001 | 83085-001-90 | 90 CAPSULE in 1 BOTTLE (83085-001-90) |
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 218202 | ANDA | SKG Pharma Inc. | 83085-002 | 83085-002-90 | 90 CAPSULE in 1 BOTTLE (83085-002-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 10, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Apr 10, 2024 | TE: | AB | RLD: | No |
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