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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091633
Company: SUN PHARM INDS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 2.5MG;200MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 10MG;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
05/28/2013 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
12/15/2023 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
05/04/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/11/2019 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/22/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/20/2018 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/14/2018 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-7 REMS - PROPOSAL - D-N-A

Label is not available on this site.
09/14/2018 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
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