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BUSPIRONE HYDROCHLORIDE از شرکت MYLAN

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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): 076008

Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription

AB

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription

AB

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription

AB

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription

AB

No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription

AB

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
06/28/2001 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

10/18/2011 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/26/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/01/2011 SUPPL-8 Labeling

Label is not available on this site.

12/23/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/2002 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/28/2002 SUPPL-2 Labeling

Label is not available on this site.

05/31/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL; 30MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078302 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

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

TABLET;ORAL; 5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

TABLET;ORAL; 10MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

TABLET;ORAL; 15MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS
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