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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091246
Company: SAGENT PHARMS

Products on ANDA 091246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091246Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091246

OXACILLIN SODIUM

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201539	EUGIA PHARMA SPECLTS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206198	FRESENIUS KABI USA
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091246	SAGENT PHARMS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207147	WOCKHARDT BIO AG

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201539	EUGIA PHARMA SPECLTS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206198	FRESENIUS KABI USA
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091246	SAGENT PHARMS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091486	STERISCIENCE
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207147	WOCKHARDT BIO AG

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