Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077781
Company: APOTEX INC

Products on ANDA 077781

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Discontinued	None	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077781

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2011	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
06/28/2023	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2021	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/08/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/14/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/18/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.