Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204644
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG 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 |
|---|---|---|---|---|---|---|---|
| 06/21/2017 | 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 |
|---|---|---|---|---|---|
| 12/09/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
IMATINIB MESYLATE
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLEEVEC | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021588 | NOVARTIS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 079179 | APOTEX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 208429 | CHARTWELL RX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212193 | CSPC OUYI |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 206547 | DR REDDYS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212773 | EUGIA PHARMA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212975 | HETERO LABS LTD V |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204644 | MYLAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 207818 | NATCO PHARMA LTD |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212135 | QILU PHARM HAINAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 208302 | SHILPA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078340 | SUN PHARM |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204285 | TEVA PHARMS USA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 210658 | ZYDUS PHARMS |
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLEEVEC | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021588 | NOVARTIS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 079179 | APOTEX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 208429 | CHARTWELL RX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212193 | CSPC OUYI |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 206547 | DR REDDYS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212773 | EUGIA PHARMA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212975 | HETERO LABS LTD V |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204644 | MYLAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 207818 | NATCO PHARMA LTD |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212135 | QILU PHARM HAINAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 208302 | SHILPA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 078340 | SUN PHARM |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204285 | TEVA PHARMS USA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 210658 | ZYDUS PHARMS |