Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209937
Company: CUSTOPHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM TETRADECYL SULFATE SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) 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
12/09/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

SODIUM TETRADECYL SULFATE

INJECTABLE;INJECTION; 60MG/2ML (30MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM TETRADECYL SULFATE SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE;INJECTION Prescription No AP 209937 CUSTOPHARM INC
SOTRADECOL SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE;INJECTION Prescription No AP 040541 MYLAN INSTITUTIONAL

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