Drugs@FDA: FDA Approved Drug Products

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

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 AUROBINDO PHARMA LTD
OXACILLIN SODIUM OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203950 HOSPIRA INC
OXACILLIN SODIUM OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206681 PIRAMAL CRITICAL
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 AUROBINDO PHARMA LTD
OXACILLIN SODIUM OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203950 HOSPIRA INC
OXACILLIN SODIUM OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206681 PIRAMAL CRITICAL
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 207147 WOCKHARDT BIO AG

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