Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206153
Company: INDOCO
Company: INDOCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG 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 |
---|---|---|---|---|---|---|---|
10/04/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/14/2021 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
RASAGILINE MESYLATE
TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZILECT | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021641 | TEVA |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201889 | ALKEM LABS LTD |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201971 | AUROBINDO PHARMA USA |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201892 | CHARTWELL RX |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206153 | INDOCO |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 207004 | MICRO LABS |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 201970 | ORBION PHARMS |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 218163 | SKG PHARMA |
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZILECT | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021641 | TEVA |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201889 | ALKEM LABS LTD |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201971 | AUROBINDO PHARMA USA |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201892 | CHARTWELL RX |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 206153 | INDOCO |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 207004 | MICRO LABS |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 201970 | ORBION PHARMS |
RASAGILINE MESYLATE | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 218163 | SKG PHARMA |