Details for New Drug Application (NDA): 015197
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The generic ingredient in AMICAR is aminocaproic acid. There are six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 015197
Tradename: | AMICAR |
Applicant: | Hikma |
Ingredient: | aminocaproic acid |
Patents: | 0 |
Pharmacology for NDA: 015197
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 015197
Suppliers and Packaging for NDA: 015197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMICAR | aminocaproic acid | TABLET;ORAL | 015197 | NDA AUTHORIZED GENERIC | Akorn Operating Company LLC | 17478-768 | 17478-768-30 | 30 TABLET in 1 BOTTLE (17478-768-30) |
AMICAR | aminocaproic acid | TABLET;ORAL | 015197 | NDA AUTHORIZED GENERIC | Akorn Operating Company LLC | 17478-769 | 17478-769-30 | 30 TABLET in 1 BOTTLE (17478-769-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Jun 24, 2004 | TE: | RLD: | Yes |
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