Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213914
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/16/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213914Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/21/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
SUNITINIB MALATE
CAPSULE;ORAL; EQ 12.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215843 | DR REDDYS |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218615 | EUGIA PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201275 | MYLAN |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218024 | NATCO PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213914 | SUN PHARM |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213803 | TEVA PHARMS USA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218012 | WANBANG BIOPHARMS |
SUTENT | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021938 | CPPI CV |
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215843 | DR REDDYS |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218615 | EUGIA PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201275 | MYLAN |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218024 | NATCO PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213914 | SUN PHARM |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213803 | TEVA PHARMS USA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218012 | WANBANG BIOPHARMS |
SUTENT | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021938 | CPPI CV |
CAPSULE;ORAL; EQ 37.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215843 | DR REDDYS |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218615 | EUGIA PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201275 | MYLAN |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218024 | NATCO PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213914 | SUN PHARM |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213803 | TEVA PHARMS USA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218012 | WANBANG BIOPHARMS |
SUTENT | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021938 | CPPI CV |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215843 | DR REDDYS |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218615 | EUGIA PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201275 | MYLAN |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218024 | NATCO PHARMA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213914 | SUN PHARM |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213803 | TEVA PHARMS USA |
SUNITINIB MALATE | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218012 | WANBANG BIOPHARMS |
SUTENT | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021938 | CPPI CV |