Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078189
Company: BARR

• Other Important Information from FDA

Products on ANDA 078189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078189ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/05/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/28/2016	SUPPL-11	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.
07/24/2013	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.

Therapeutic Equivalents for ANDA 078189

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;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	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204895	AUROBINDO PHARMA
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078189	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	090178	SUN PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079028	WATSON LABS

CAPSULE, EXTENDED RELEASE;ORAL; EQ 16MG 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 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204895	AUROBINDO PHARMA
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078189	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	090178	SUN PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079028	WATSON LABS

CAPSULE, EXTENDED RELEASE;ORAL; EQ 24MG 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 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204895	AUROBINDO PHARMA
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078189	BARR
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	090178	SUN PHARM
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079028	WATSON LABS