Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 078782
Company: HIKMA PHARMS
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Discontinued | None | No | No |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/21/2011 | 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 |
|---|---|---|---|---|---|
| 02/29/2016 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/29/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/29/2016 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2012 | SUPPL-2 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 04/17/2012 | SUPPL-1 | Labeling-Package Insert |
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