Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090158
Company: MYLAN

Products on ANDA 090158

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 090158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2011	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
03/28/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.