Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078150
Company: HIKMA

Products on ANDA 078150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Discontinued	None	No	No
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Discontinued	None	No	No
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2007	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
08/02/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/10/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/10/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/20/2012	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/30/2012	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/25/2011	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/05/2012	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/29/2011	SUPPL-9	Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
04/05/2012	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
11/18/2009	SUPPL-2	Labeling		Label is not available on this site.