Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206133
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EVEROLIMUS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | AB | No | No |
EVEROLIMUS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
EVEROLIMUS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | AB | No | No |
EVEROLIMUS | EVEROLIMUS | 1MG | 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 |
---|---|---|---|---|---|---|---|
04/12/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206133Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/30/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
EVEROLIMUS
TABLET;ORAL; 0.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | No | AB | 214138 | ALKEM LABS LTD |
EVEROLIMUS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | No | AB | 205432 | BRECKENRIDGE |
EVEROLIMUS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | No | AB | 206133 | HIKMA |
EVEROLIMUS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | No | AB | 205775 | PAR PHARM |
ZORTRESS | EVEROLIMUS | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 021560 | NOVARTIS |
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 214138 | ALKEM LABS LTD |
EVEROLIMUS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 205432 | BRECKENRIDGE |
EVEROLIMUS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206133 | HIKMA |
EVEROLIMUS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | No | AB | 205775 | PAR PHARM |
ZORTRESS | EVEROLIMUS | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 021560 | NOVARTIS |
TABLET;ORAL; 0.75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | No | AB | 214138 | ALKEM LABS LTD |
EVEROLIMUS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | No | AB | 205432 | BRECKENRIDGE |
EVEROLIMUS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | No | AB | 206133 | HIKMA |
EVEROLIMUS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | No | AB | 205775 | PAR PHARM |
ZORTRESS | EVEROLIMUS | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 021560 | NOVARTIS |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | EVEROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 214138 | ALKEM LABS LTD |
EVEROLIMUS | EVEROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 206133 | HIKMA |
EVEROLIMUS | EVEROLIMUS | 1MG | TABLET;ORAL | Prescription | No | AB | 205775 | PAR PHARM |
ZORTRESS | EVEROLIMUS | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021560 | NOVARTIS |