Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077795
Company: HIKMA

• Healthcare Professional Sheet

Products on ANDA 077795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Discontinued	None	No	No
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Discontinued	None	No	No
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/2007	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077795s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/26/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/25/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/06/2012	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal		Label is not available on this site.
08/29/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/29/2010	SUPPL-3	Labeling		Label is not available on this site.

Labels for ANDA 077795

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf