Details for New Drug Application (NDA): 216804
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NDA 216804 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Amneal, Annora Pharma, Aurobindo Pharma, Belcher, Carnegie, Epic Pharma Llc, Florida, MSN, Sunny, Taro, Trupharma, Vistapharm Llc, Adaptis, Ani Pharms, and Appco, and is included in twenty-four NDAs. It is available from seventeen 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 216804
| Tradename: | AMINOCAPROIC ACID |
| Applicant: | Aurobindo Pharma |
| Ingredient: | aminocaproic acid |
| Patents: | 0 |
Pharmacology for NDA: 216804
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 216804
Suppliers and Packaging for NDA: 216804
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOCAPROIC ACID | aminocaproic acid | SOLUTION;ORAL | 216804 | ANDA | Aurobindo Pharma Limited | 59651-573 | 59651-573-08 | 236.5 mL in 1 BOTTLE (59651-573-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.25GM/ML | ||||
| Approval Date: | Sep 26, 2022 | TE: | AA | RLD: | No | ||||
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