Details for New Drug Application (NDA): 071192
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The generic ingredient in AMINOCAPROIC ACID is aminocaproic acid. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 071192
Tradename: | AMINOCAPROIC ACID |
Applicant: | Luitpold |
Ingredient: | aminocaproic acid |
Patents: | 0 |
Pharmacology for NDA: 071192
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 071192
Suppliers and Packaging for NDA: 071192
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | aminocaproic acid | INJECTABLE;INJECTION | 071192 | ANDA | American Regent, Inc. | 0517-9120 | 0517-9120-25 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9120-25) / 20 mL in 1 VIAL, MULTI-DOSE |
AMINOCAPROIC ACID | aminocaproic acid | INJECTABLE;INJECTION | 071192 | ANDA | American Regent, Inc. | 0517-9191 | 0517-9191-25 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/ML | ||||
Approval Date: | Dec 1, 1987 | TE: | AP | RLD: | No |
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