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Last Updated: February 22, 2024

Details for New Drug Application (NDA): 016750

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NDA 016750 describes CORTROSYN, which is a drug marketed by Amphastar Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the CORTROSYN profile page.

The generic ingredient in CORTROSYN is cosyntropin. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cosyntropin profile page.
Summary for 016750
Applicant:Amphastar Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 016750
Medical Subject Heading (MeSH) Categories for 016750
Suppliers and Packaging for NDA: 016750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORTROSYN cosyntropin INJECTABLE;INJECTION 016750 NDA Henry Schein, Inc. 0404-9839 0404-9839-99 1 VIAL in 1 BAG (0404-9839-99) / 1 mL in 1 VIAL
CORTROSYN cosyntropin INJECTABLE;INJECTION 016750 NDA Amphastar Pharmaceuticals, Inc. 0548-5900 0548-5900-00 10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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