Details for New Drug Application (NDA): 015229
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NDA 015229 describes AMICAR, which is a drug marketed by Epic Pharma Llc and Hikma and is included in three NDAs. It is available from one supplier. Additional details are available on the AMICAR profile page.
The generic ingredient in AMICAR is aminocaproic acid. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
The generic ingredient in AMICAR is aminocaproic acid. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 015229
| Tradename: | AMICAR |
| Applicant: | Epic Pharma Llc |
| Ingredient: | aminocaproic acid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 015229
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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