Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 100MG | TABLET;ORAL | Prescription | AB1 | No | No |
GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | AB1 | No | No |
GABAPENTIN | GABAPENTIN | 400MG | TABLET;ORAL | Prescription | AB1 | No | No |
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 |
---|---|---|---|---|---|---|---|
04/28/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76017ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/20/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
07/20/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2014 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
07/19/2012 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
04/16/2012 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
09/29/2011 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2011 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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11/18/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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07/14/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/28/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
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01/17/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/20/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/29/2005 | SUPPL-9 |
Label is not available on this site. |
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04/29/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/29/2005 | SUPPL-5 |
Label is not available on this site. |
|||
04/29/2005 | SUPPL-4 |
Label is not available on this site. |
|||
09/20/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
GABAPENTIN
TABLET;ORAL; 100MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 100MG | TABLET;ORAL | Prescription | No | AB1 | 077894 | APOTEX |
GABAPENTIN | GABAPENTIN | 100MG | TABLET;ORAL | Prescription | No | AB1 | 076017 | IVAX SUB TEVA PHARMS |
TABLET;ORAL; 300MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB1 | 077894 | APOTEX |
GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB1 | 076017 | IVAX SUB TEVA PHARMS |
TABLET;ORAL; 400MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 400MG | TABLET;ORAL | Prescription | No | AB1 | 077894 | APOTEX |
GABAPENTIN | GABAPENTIN | 400MG | TABLET;ORAL | Prescription | No | AB1 | 076017 | IVAX SUB TEVA PHARMS |