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OXACILLIN SODIUM

ANDA

OXACILLIN SODIUM | A061490 | SANDOZ INC

5 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0848 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that FDA designate Oxacillin for Injection 1g and 2g in ADD-Vantage Vial approved under ANDA No. 062737 as a Reference Listed Drug, allowing generic appli	Other	2013-07-23	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

Products (5)

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#001 — EQ 250MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 2GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#006 — EQ 10GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 9, 1991