Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201971
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
05/15/2017 | ORIG-1 | Approval | Not Applicable |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201971Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201971Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/14/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/02/2020 | SUPPL-3 | 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 |
---|---|---|---|---|---|
05/15/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201971Orig1s000lbl.pdf |
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 | 208866 | MACLEODS PHARMS LTD |
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 | 208866 | MACLEODS PHARMS LTD |
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 |