Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077454
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Discontinued None 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
06/23/2010 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
07/22/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/21/2018 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/15/2018 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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