Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076606
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 |
---|---|---|---|---|---|---|---|
10/07/2005 | 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 |
---|---|---|---|---|---|
09/23/2011 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
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05/13/2010 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/06/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |