Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075435
Company: TEVA PHARMS
Company: TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 10/08/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75435ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/30/2011 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/30/2011 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2011 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2013 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/14/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/10/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/22/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/05/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |