Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040541
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTRADECOL SODIUM TETRADECYL SULFATE 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription None No Yes
SOTRADECOL SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/12/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40541ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/30/2008 SUPPL-4 Labeling

Label is not available on this site.

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