Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077604
Company: YABAO PHARM

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/06/2009 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
12/27/2017 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 077781 APOTEX INC
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 077593 DR REDDYS LABS LTD
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077587 HERITAGE PHARMA
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077590 MYLAN
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 077608 WEST-WARD PHARMS INT
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
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 021169 JANSSEN PHARMS

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 077781 APOTEX INC
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 077593 DR REDDYS LABS LTD
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077587 HERITAGE PHARMA
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077590 MYLAN
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 077608 WEST-WARD PHARMS INT
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
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET;ORAL Prescription Yes AB 021169 JANSSEN PHARMS

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 077781 APOTEX INC
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 077593 DR REDDYS LABS LTD
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET;ORAL Prescription No AB 077587 HERITAGE PHARMA
GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET;ORAL Prescription No AB 077590 MYLAN
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 077608 WEST-WARD PHARMS INT
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
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET;ORAL Prescription Yes AB 021169 JANSSEN PHARMS

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