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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. Four suppliers are listed for this compound. Additional details are available on the cosyntropin profile page.

Summary for NDA: 016750

Tradename:
CORTROSYN
Applicant:
Amphastar Pharms Inc
Ingredient:
cosyntropin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Amphastar Pharmaceuticals, Inc. 0548-5900 0548-5900-00 10 VIAL in 1 CARTON (0548-5900-00) > 1 mL in 1 VIAL
CORTROSYN
cosyntropin
INJECTABLE;INJECTION 016750 NDA General Injectables & Vaccines, Inc 52584-050 52584-050-00 1 VIAL in 1 BAG (52584-050-00) > 1 mL in 1 VIAL

Summary 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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