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DICLOXACILLIN SODIUM

ANDA

DICLOXACILLIN SODIUM | A216845 | AUROBINDO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain1 active DMF8 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

APITORIA PHARMA PRIVATE LTDDICLOXACILLIN SODIUM USP

DMF 195532006

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveDICLOXACILLIN SODIUM

DMF 132211998

FERMENTA PRODUCTS INCInactiveDICLOXACILLIN SODIUM

DMF 133521998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134291998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134311998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveDICLOXACILLIN SODIUM MONOHYDRATE

DMF 134971998

BARCELONETA INC DIV BRISTOL MYERSInactiveDICLOXACILLIN SODIUM

DMF 135581998

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDICLOXACILLIN SODIUM

DMF 136571998

SANDOZ INDUSTRIAL PRODUCTS SAInactiveDICLOXACILLIN SODIUM

DMF 137981998

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 250MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 23, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 23, 2022