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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201448
Company: NOSTRUM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG/5ML;5MG/5ML SOLUTION;ORAL Prescription AA 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
08/26/2021 ORIG-1 Approval Not Applicable

Label is not available on this site.

OXYCODONE AND ACETAMINOPHEN

SOLUTION;ORAL; 325MG/5ML;5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG/5ML;5MG/5ML SOLUTION;ORAL Prescription No AA 211499 ABHAI LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG/5ML;5MG/5ML SOLUTION;ORAL Prescription No AA 201448 NOSTRUM LABS INC
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