Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075119
Company: EGIS
Company: EGIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/14/2002 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75119ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75119ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/23/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/23/2003 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |