Details for New Drug Application (NDA): 015197
✉ Email this page to a colleague
NDA 015197 describes AMICAR, which is a drug marketed by Epic Pharma Llc and Hikma and is included in three NDAs. It is available from two suppliers. 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-one 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-one 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 | Hikma Pharmaceuticals USA Inc. | 0054-1110 | 0054-1110-13 | 30 TABLET in 1 BOTTLE (0054-1110-13) |
| 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) |
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 | |||||
Complete Access Available with Subscription
