Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203107
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | 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 |
---|---|---|---|---|---|---|---|
07/26/2012 | 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 |
---|---|---|---|---|---|
09/18/2018 | SUPPL-2 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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06/29/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |