Details for New Drug Application (NDA): 070010
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NDA 070010 describes AMINOCAPROIC ACID IN PLASTIC CONTAINER, which is a drug marketed by Hospira and is included in one NDA. It is available from two suppliers. Additional details are available on the AMINOCAPROIC ACID IN PLASTIC CONTAINER profile page.
The generic ingredient in AMINOCAPROIC ACID IN PLASTIC CONTAINER 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 IN PLASTIC CONTAINER 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 070010
| Tradename: | AMINOCAPROIC ACID IN PLASTIC CONTAINER |
| Applicant: | Hospira |
| Ingredient: | aminocaproic acid |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070010
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 070010
Suppliers and Packaging for NDA: 070010
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOCAPROIC ACID IN PLASTIC CONTAINER | aminocaproic acid | INJECTABLE;INJECTION | 070010 | ANDA | Henry Schein, Inc. | 0404-9812 | 0404-9812-20 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9812-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
| AMINOCAPROIC ACID IN PLASTIC CONTAINER | aminocaproic acid | INJECTABLE;INJECTION | 070010 | ANDA | Hospira, Inc. | 0409-4346 | 0409-4346-73 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/ML | ||||
| Approval Date: | Mar 9, 1987 | TE: | AP | RLD: | No | ||||
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