Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
01/15/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079063s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/28/2024 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/28/2024 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/28/2024 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/28/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/28/2024 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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08/14/2017 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/28/2024 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/28/2024 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/28/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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11/03/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/03/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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11/03/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2013 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/26/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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12/13/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
06/30/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
LEVETIRACETAM
SOLUTION;ORAL; 100MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KEPPRA | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021505 | UCB INC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078582 | ACI |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078976 | ACTAVIS MID ATLANTIC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203067 | ALEMBIC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090992 | AMNEAL PHARMS |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079063 | AUROBINDO PHARMA |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090461 | BELCHER |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079120 | BIONPHARMA |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090263 | CHARTWELL MOLECULAR |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203052 | HETERO LABS LTD III |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090893 | LUPIN LTD |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214757 | MSN |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 201157 | PHARM ASSOC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090079 | QUAGEN |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078774 | TARO |