Details for New Drug Application (NDA): 090664
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The generic ingredient in NICARDIPINE HYDROCHLORIDE 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 090664
Tradename: | NICARDIPINE HYDROCHLORIDE |
Applicant: | Rk Pharma |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 090664
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | INJECTABLE;INJECTION | 090664 | ANDA | Archis Pharma LLC | 72819-149 | 72819-149-07 | 10 VIAL in 1 CARTON (72819-149-07) / 10 mL in 1 VIAL (72819-149-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/10ML (2.5MG/ML) | ||||
Approval Date: | Nov 17, 2009 | TE: | AP | RLD: | No |
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