Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202147
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/29/2012 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202147Orig1s000Approv.pdf

COSYNTROPIN

INJECTABLE;INJECTION; 0.25MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTROSYN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 016750 AMPHASTAR PHARMS INC
COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription No AP 090574 MYLAN INSTITUTIONAL
COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE;INJECTION Prescription No AP 202147 SANDOZ

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