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Drugs@FDA: FDA-Approved Drugs

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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;INTRAVENOUS Prescription AP 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
03/22/2016 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/24/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/31/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ACETAMINOPHEN

SOLUTION;INTRAVENOUS; 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;INTRAVENOUS Prescription No AP 216617 ASPIRO
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214331 BAXTER HLTHCARE CORP
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210969 EUGIA PHARMA
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 202605 HIKMA
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 213255 MYLAN
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204052 SANDOZ INC
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216467 ZYDUS PHARMS
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