Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204052
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;IV (INFUSION) 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
03/22/2016 ORIG-1 Approval

Label is not available on this site.

ACETAMINOPHEN

SOLUTION;IV (INFUSION); 1GM/100ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 202605 CUSTOPHARM INC
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 204052 SANDOZ INC
OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;IV (INFUSION) Prescription Yes AP 022450 MALLINCKRODT IP

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