Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201578
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | AB | No | No |
SIROLIMUS | SIROLIMUS | 2MG | 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 |
---|---|---|---|---|---|---|---|
10/27/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2023 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/31/2023 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2023 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
SIROLIMUS
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RAPAMUNE | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021110 | PF PRISM CV |
SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 214753 | ALKEM LABS LTD |
SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 201578 | DR REDDYS |
SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 208691 | GLENMARK PHARMS LTD |
SIROLIMUS | SIROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 201676 | ZYDUS PHARMS |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RAPAMUNE | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | Yes | AB | 021110 | PF PRISM CV |
SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 214753 | ALKEM LABS LTD |
SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 201578 | DR REDDYS |
SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 208691 | GLENMARK PHARMS LTD |
SIROLIMUS | SIROLIMUS | 2MG | TABLET;ORAL | Prescription | No | AB | 201676 | ZYDUS PHARMS |