Drugs@FDA: FDA Approved Drug Products

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
07/20/2012 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/29/2011 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels, REMS-Proposal

Label is not available on this site.

04/05/2012 SUPPL-8 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/18/2009 SUPPL-2 Labeling

Label is not available on this site.

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