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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

Amphastar Pharms Inc
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
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
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.