Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074997
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
10/15/1997 | 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 |
---|---|---|---|---|---|
01/11/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/27/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |