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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075022
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG 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
02/28/2002 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
05/29/2020 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

11/27/2012 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

08/26/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/29/2015 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/18/2008 SUPPL-9 Labeling

Label is not available on this site.

03/16/2007 SUPPL-8 Labeling

Label is not available on this site.

02/26/2003 SUPPL-2 Labeling

Label is not available on this site.

03/26/2004 SUPPL-1

Label is not available on this site.

BUSPIRONE HYDROCHLORIDE

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

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
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