Abbreviated New Drug Application (ANDA): 203490
Company: ANI PHARMS INC
Company: ANI PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 07/13/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2021 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2020 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2019 | SUPPL-3 | 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 203959 | WATSON LABS TEVA |
| 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 203959 | WATSON LABS TEVA |
| 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 203959 | WATSON LABS TEVA |
| 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Prescription | No | AB | 203959 | WATSON LABS TEVA |
| 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| 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 |
|---|---|---|---|---|---|---|---|---|
| TEMODAR | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 021029 | MERCK SHARP DOHME |
| 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 | 203490 | ANI PHARMS INC |
| 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 | 206309 | RISING |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 201742 | SUN PHARM |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 203959 | WATSON LABS TEVA |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 206750 | ZYDUS PHARMS |