Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077242
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
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 |
---|---|---|---|---|---|---|---|
08/24/2006 | 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 |
---|---|---|---|---|---|
10/27/2020 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/07/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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08/07/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/07/2020 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/10/2015 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/12/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/12/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/30/2011 | SUPPL-10 | REMS-Proposal |
Label is not available on this site. |
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03/30/2011 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/13/2010 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |