Details for New Drug Application (NDA): 212780
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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 212780
Tradename: | AMINOCAPROIC ACID |
Applicant: | Amneal |
Ingredient: | aminocaproic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212780
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 212780
Suppliers and Packaging for NDA: 212780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | aminocaproic acid | SOLUTION;ORAL | 212780 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1596 | 69238-1596-4 | 10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3) |
AMINOCAPROIC ACID | aminocaproic acid | SOLUTION;ORAL | 212780 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1596 | 69238-1596-8 | 236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.25GM/ML | ||||
Approval Date: | Aug 23, 2019 | TE: | AA | RLD: | No |
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