Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077605
Company: BARR
Company: BARR
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 |
---|---|---|---|---|---|---|---|
08/28/2008 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2016 | SUPPL-9 | 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. |
||
01/28/2013 | 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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/28/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf |
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 | 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 | 077589 | SANDOZ |
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 |
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 | 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 | 077589 | SANDOZ |
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 |
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 | 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 | 077589 | SANDOZ |
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 |