Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078189
Company: BARR
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 |
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 |
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 |
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 |