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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204895
Company: AUROBINDO PHARMA
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
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
03/17/2022 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/17/2022 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

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.

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
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
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
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
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
RAZADYNE ER GALANTAMINE HYDROBROMIDE EQ 24MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021615 JANSSEN PHARMS
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