Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079028
Company: WATSON LABS
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 PHARM |
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 PHARM |
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 PHARM |
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 |
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