Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079028
Company: WATSON LABS

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
12/15/2008 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
12/14/2017 SUPPL-10 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English