U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078734
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription AB 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
06/26/2009 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078734s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078734Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/05/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/04/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/04/2015 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/12/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/04/2015 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

OXCARBAZEPINE

SUSPENSION;ORAL; 300MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 211420 AKORN
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 202961 AMNEAL PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 215332 AUCTA
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 209652 BIONPHARMA INC
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 212428 GLASSHOUSE PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 201193 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 215726 RUBICON
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 078734 SUN PHARM INDS LTD
TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription Yes AB 021285 NOVARTIS
Back to Top