Drugs@FDA: FDA Approved Drug Products

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

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 LTD
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 PHARMA GLOBAL
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079028 WATSON LABS
RAZADYNE ER GALANTAMINE HYDROBROMIDE EQ 8MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021615 JANSSEN PHARMS

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 LTD
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 PHARMA GLOBAL
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 16MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079028 WATSON LABS
RAZADYNE ER GALANTAMINE HYDROBROMIDE EQ 16MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021615 JANSSEN PHARMS

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 LTD
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 PHARMA GLOBAL
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 24MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079028 WATSON LABS
RAZADYNE ER GALANTAMINE HYDROBROMIDE EQ 24MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021615 JANSSEN PHARMS

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