Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205233
Company: ALEMBIC
Company: ALEMBIC
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 | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205233Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/17/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2018 | 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 PHARMA |
LINEZOLID | LINEZOLID | 600MG | TABLET;ORAL | Prescription | No | AB | 206097 | ZYDUS PHARMS |
ZYVOX | LINEZOLID | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021130 | PFIZER |