BUSPIRONE HYDROCHLORIDE از شرکت MYLAN

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 MYLAN

Abbreviated New Drug Application (ANDA): 075467

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 Prescription

AB

No Yes
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.

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL; 7.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 075467 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
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