Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077604
Company: YABAO PHARM
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 | Yes |
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 |
---|---|---|---|---|---|
06/28/2023 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/28/2023 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/27/2017 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 | 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 |