Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 201157
Company: PHARM ASSOC
Company: PHARM ASSOC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/04/2015 | ORIG-1 | Approval | Not Applicable |
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 | 078976 | ACTAVIS MID ATLANTIC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090992 | AMNEAL PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079063 | AUROBINDO PHARMA LTD |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079120 | BRECKENRIDGE PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203052 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090601 | HI-TECH PHARMACAL |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090079 | LANNETT CO INC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090263 | LANNETT CO INC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090893 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203067 | ORIT LABS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 201157 | PHARM ASSOC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078774 | TARO |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079107 | TOLMAR |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090461 | TRIS PHARMA INC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090028 | WOCKHARDT BIO AG |
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