Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075137
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 | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 12/18/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75137ltr.pdf |
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 | 074520 | LANNETT CO INC |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075137 | PHARM ASSOC |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074868 | WOCKHARDT BIO AG |
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