Details for New Drug Application (NDA): 212494
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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 212494
Tradename: | AMINOCAPROIC ACID |
Applicant: | Tulex Pharms Inc |
Ingredient: | aminocaproic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212494
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 212494
Suppliers and Packaging for NDA: 212494
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | aminocaproic acid | SOLUTION;ORAL | 212494 | ANDA | TruPharma LLC | 52817-815 | 52817-815-08 | 236.5 mL in 1 BOTTLE, PLASTIC (52817-815-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.25GM/ML | ||||
Approval Date: | Aug 11, 2020 | TE: | AA | RLD: | No |
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