Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078987
Company: GLENMARK SPECLT
Company: GLENMARK SPECLT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LINEZOLID | LINEZOLID | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/2015 | 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 |
|---|---|---|---|---|---|
| 09/23/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2024 | SUPPL-7 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/23/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2018 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2018 | SUPPL-3 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/31/2018 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LINEZOLID
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 205233 | ALEMBIC |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 205517 | ALKEM LABS LTD |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 210702 | CHARTWELL RX |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 078987 | GLENMARK SPECLT |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 204239 | HETERO LABS LTD V |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 207526 | NOVEL LABS INC |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 078845 | RISING |
| LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 206097 | ZYDUS PHARMS |