U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078150
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Discontinued None No No
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Discontinued None No No
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Discontinued None 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
09/25/2007 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2023 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
08/10/2020 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/10/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
07/20/2012 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
04/30/2012 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/25/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
04/05/2012 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/29/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.
04/05/2012 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.
11/18/2009 SUPPL-2 Labeling

Label is not available on this site.
Back to Top