Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205154
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
12/06/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205154Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/12/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/27/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
06/27/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LINEZOLID
SOLUTION;INTRAVENOUS; 200MG/100ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207001 | HQ SPCLT PHARMA |
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205154 | MYLAN LABS LTD |
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207354 | NANG KUANG PHARM CO |
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204696 | SAGENT PHARMS INC |
LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 200904 | SANDOZ |
ZYVOX | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021131 | PFIZER |
SOLUTION;INTRAVENOUS; 600MG/300ML (2MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206917 | EUGIA PHARMA |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204764 | FRESENIUS KABI USA |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206454 | HIKMA |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207001 | HQ SPCLT PHARMA |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205154 | MYLAN LABS LTD |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207354 | NANG KUANG PHARM CO |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204696 | SAGENT PHARMS INC |
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 200904 | SANDOZ |
ZYVOX | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021131 | PFIZER |