Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091627
Company: SAGENT PHARMS
Company: SAGENT PHARMS
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 |
---|---|---|---|---|---|---|---|
06/26/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/13/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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07/13/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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07/13/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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07/13/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2016 | 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 |