Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204895
Company: AUROBINDO PHARMA

Products on ANDA 204895

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	Yes
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 204895

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2016	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
01/17/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/17/2022	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/17/2022	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/17/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/24/2019	SUPPL-3	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204895

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