Details for New Drug Application (NDA): 015197
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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 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-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 |
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) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Jun 24, 2004 | TE: | AB | RLD: | Yes | ||||
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