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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077605
Company: BARR

Other Important Information from FDA

Products on ANDA 077605

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	AB	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/28/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/10/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/12/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/28/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/11/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 077605

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf

Therapeutic Equivalents for ANDA 077605

GALANTAMINE HYDROBROMIDE

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	090957	AUROBINDO PHARMA LTD
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077605	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077589	SANDOZ
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077593	SENORES PHARMS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077604	YABAO PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	078898	ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	090957	AUROBINDO PHARMA LTD
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077605	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077589	SANDOZ
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077593	SENORES PHARMS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077604	YABAO PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	078898	ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 12MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	090957	AUROBINDO PHARMA LTD
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	077605	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	077589	SANDOZ
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	077593	SENORES PHARMS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	077604	YABAO PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET;ORAL	Prescription	No	AB	078898	ZYDUS PHARMS USA INC

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