Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207012
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG 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 |
---|---|---|---|---|---|---|---|
09/10/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207012Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/05/2024 | SUPPL-3 | Labeling, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
SORAFENIB TOSYLATE
TABLET;ORAL; EQ 200MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEXAVAR | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021923 | BAYER HLTHCARE |
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 216073 | DR REDDYS |
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 207012 | MYLAN |
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 209567 | TEVA PHARMS USA INC |
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 217095 | TORRENT |
SORAFENIB TOSYLATE | SORAFENIB TOSYLATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 209050 | YABAO PHARM |