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BACTOCILL IN PLASTIC CONTAINER

NDA

OXACILLIN SODIUM | N050640 | BAXTER HEALTHCARE CORP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs9 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPAOXACILLIN SODIUM STERILE CRYSTALLINE (BULK)

DMF 137431998

APITORIA PHARMA PRIVATE LTDOXACILLIN SODIUM USP

DMF 192382006

APITORIA PHARMA PRIVATE LTDOXACILLIN FOR INJECTION USP (STERILE BULK)

DMF 224642009

PURE AND CURE HEALTHCARE PRIVATE LTDOXACILLIN SODIUM USP

DMF 246782011

SANDOZ INDUSTRIAL PRODUCTS SAInactiveOXACILLIN SODIUM

DMF 132161998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveOXACILLIN SODIUM MONOHYDRATE

DMF 133861998

BRISTOL MYERS SQUIBB COInactiveOXACILLIN SODIUM

DMF 134321998

LATINA PHARMA SPAInactiveOXACILLIN SODIUM

DMF 134331998

BARCELONETA INC DIV BRISTOL MYERSInactiveOXACILLIN SODIUM

DMF 135531998

TEVA PHARMACEUTICALS USA INCInactiveOXACILLIN SODIUM

DMF 136171998

ACS DOBFAR SPAInactiveOXACILLIN SODIUM

DMF 136961998

ACS DOBFAR SPAInactiveOXACILLIN SODIUM MONOHYDRATE FOR INJECTION

DMF 152431999

APOTHECON INC DIV BRISTOL MYERS SQUIBBInactiveOXACILLIN SODIUM FOR ORAL SOLUTION

DMF 152452001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2017	SUPPL -20	View Letter (PDF)
Jan 8, 2015	SUPPL -17	View Letter (PDF)
Nov 23, 2012	SUPPL -15	View Letter (PDF)
Oct 17, 2011	SUPPL -11	View Letter (PDF)
Apr 22, 2008	SUPPL -10	View Letter (PDF)
Mar 24, 2004	SUPPL -7	View Letter (PDF)
Aug 23, 2002	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 20MG BASE/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 26, 1989

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 26, 1989