Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211212
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
10/18/2019 | 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 |
---|---|---|---|---|---|
07/28/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
07/28/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
SIROLIMUS
SOLUTION;ORAL; 1MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RAPAMUNE | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021083 | PF PRISM CV |
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 211212 | AMNEAL |
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 211406 | APOTEX |
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 215080 | HETERO LABS LTD V |
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216728 | MSN |
SIROLIMUS | SIROLIMUS | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 211040 | NOVITIUM PHARMA |