BUSPIRONE HYDROCHLORIDE از شرکت IVAX SUB TEVA PHARMS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BUSPIRONE HYDROCHLORIDE از شرکت IVAX SUB TEVA PHARMS

Abbreviated New Drug Application (ANDA): 075385

Company: IVAX SUB TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

None

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

None

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued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
03/01/2002 ORIG-1 Approval

Letter (PDF)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75388TA.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75385ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/06/2008 SUPPL-5 Labeling

Label is not available on this site.

04/27/2005 SUPPL-3 Labeling

Label is not available on this site.

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