Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075467
Company: MYLAN
Company: MYLAN
| 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 | 7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75467ltr&TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-467_Buspirone.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/28/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/30/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/23/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/23/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf |
| 02/28/2002 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf |
| 02/28/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |