Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203308
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;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 |
---|---|---|---|---|---|---|---|
09/16/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203308Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LEVETIRACETAM
INJECTABLE;INTRAVENOUS; 500MG/5ML (100MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KEPPRA | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021872 | UCB INC |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204312 | EUGIA PHARMA |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090876 | FRESENIUS KABI USA |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209781 | HAINAN POLY PHARM |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090981 | HIKMA FARMACEUTICA |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202869 | HOSPIRA INC |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211954 | MICRO LABS |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215980 | MSN |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203308 | MYLAN LABS LTD |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209474 | PRINSTON INC |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091627 | SAGENT PHARMS |
LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091485 | XGEN PHARMS |