Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201538
Company: EUGIA PHARMA SPECLTS

Products on ANDA 201538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201538

OXACILLIN SODIUM

INJECTABLE;INJECTION; EQ 10GM 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 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201538	EUGIA PHARMA SPECLTS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206199	FRESENIUS KABI USA
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091245	SAGENT PHARMS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207148	WOCKHARDT BIO AG