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Generated: November 17, 2018

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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 one supplier. 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 four drug master file entries for this compound. Five 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 EffectDecreased 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 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)
AMINOCAPROIC ACID IN PLASTIC CONTAINER aminocaproic acid INJECTABLE;INJECTION 070010 ANDA Hospira, Inc. 0409-4346 0409-4346-10 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-4346-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/ML
Approval Date:Mar 9, 1987TE:APRLD:No

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