Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075388
Company: OXFORD PHARMS

Products on ANDA 075388

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2002	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
05/28/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/16/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075388

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	202087	AIPING PHARM INC
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	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	202087	AIPING PHARM INC
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	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	202087	AIPING PHARM INC
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	078888	ZYDUS PHARMS