Details for New Drug Application (NDA): 209060
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NDA 209060 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Zenara, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, Epic Pharma Llc, MSN, Regcon Holdings, Sciegen Pharms, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, and Somerset Theraps Llc, and is included in twenty-six NDAs. It is available from eighteen suppliers. Additional details are available on the AMINOCAPROIC ACID profile page.
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.
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 209060
| Tradename: | AMINOCAPROIC ACID |
| Applicant: | Sunny |
| Ingredient: | aminocaproic acid |
| Patents: | 0 |
Pharmacology for NDA: 209060
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 209060
Suppliers and Packaging for NDA: 209060
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOCAPROIC ACID | aminocaproic acid | TABLET;ORAL | 209060 | ANDA | American Health Packaging | 60687-739 | 60687-739-25 | 30 BLISTER PACK in 1 CARTON (60687-739-25) / 1 TABLET in 1 BLISTER PACK (60687-739-95) |
| AMINOCAPROIC ACID | aminocaproic acid | TABLET;ORAL | 209060 | ANDA | Vitruvias Therapeutics | 69680-115 | 69680-115-00 | 100 TABLET in 1 BOTTLE (69680-115-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 27, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Nov 27, 2018 | TE: | AB | RLD: | No | ||||
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