Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | 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 |
---|---|---|---|---|---|---|---|
02/12/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201742Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/25/2021 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
06/25/2021 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/22/2017 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/09/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
06/10/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2015 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
TEMOZOLOMIDE
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |
CAPSULE;ORAL; 140MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |
CAPSULE;ORAL; 180MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 201528 | ACCORD HLTHCARE |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 203691 | AMNEAL PHARMS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 206413 | CHARTWELL |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 204639 | CHEMI SPA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 207658 | DEVA HOLDING AS |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 210030 | HETERO LABS LTD V |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213328 | NIVAGEN PHARMS INC |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 206309 | RISING PHARMA |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |