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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204979
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 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
06/01/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204979Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2020 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/11/2020 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-4 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/11/2020 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208593 ABHAI LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208817 AKORN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 211748 ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204979 ANI PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 209021 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207511 EYWA
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 200535 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204037 HIKMA
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 206914 PHARM ASSOC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 213761 QUAGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 201194 VISTAPHARM
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