Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074520
Company: LANNETT CO INC
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/29/1996 | 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 |
---|---|---|---|---|---|
11/02/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/20/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/11/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/04/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
OXYBUTYNIN CHLORIDE
SYRUP;ORAL; 5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075039 | CHARTWELL RX |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074520 | LANNETT CO INC |