Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079107
Company: TOLMAR
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/2009/079107s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/03/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/03/2014 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/26/2012 SUPPL-11 Labeling-Package Insert, REMS

Label is not available on this site.

11/03/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/20/2009 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert, REMS-Proposal

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 078582 ALLIED PHARMA INC
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 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 090263 SILARX
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 090079 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090028 WOCKHARDT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English