Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206547
Company: DR REDDYS
Company: DR REDDYS
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 |
---|---|---|---|---|---|---|---|
08/13/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2023 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/16/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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08/16/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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08/16/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2021 | SUPPL-1 | Labeling-Container/Carton Labels, 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 | 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 | 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 | 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 | 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 |