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NAPROXEN SODIUM

ANDA

NAPROXEN SODIUM | A202807 | CATALENT PHARMA SOLUTIONS LLC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PATHEON SOFTGELS INC. et al v. OHM LABORATORIES INC. 3:2018cv00486 1 patentANDA 202807Naproxen Sodium	D.N.J.	2018-01-12	Terminated 2018-05-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain8 active DMFs12 inactive

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

DR REDDYS LABORATORIES LTDNAPROXEN SODIUM

DMF 32081978

TAPI NL BVNAPROXEN SODIUM

DMF 87461990

DR REDDYS LABORATORIES LTDNAPROXEN SODIUM

DMF 123421997

DIVIS LABORATORIES LTDNAPROXEN SODIUM USP

DMF 138671998

APITORIA PHARMA PRIVATE LTDNAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE

DMF 228322009

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDNAPROXEN SODIUM GRANULE

DMF 264022012

SOLARA ACTIVE PHARMA SCIENCES LTDNAPROXEN SODIUM USP

DMF 375262022

HETERO LABS LTDNAPROXEN SODIUM

DMF 382162023

DINAMITE DIPHARMA SPAInactiveNAPROXEN SODIUM

DMF 54781984

CAMBREX PROFARMACO MILANO SRLInactiveNAPROXEN SODIUM

DMF 67121986

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveNAPROXEN SODIUM USP

DMF 71311987

ZAMBON SPAInactiveNAPROXEN SODIUM

DMF 74561988

RALLIS INDIA LTDInactiveNAPROXEN SODIUM

DMF 75691988

ALFA WASSERMANN SPAInactiveNAPROXEN SODIUM

DMF 84361990

FARCHEMIA SRLInactiveNAPROXEN SODIUM USP

DMF 116271996

ALBEMARLE CORPInactiveNAPROXEN SODIUM

DMF 119401996

VERA LABORATORIES LTDInactiveNAPROXEN SODIUM

DMF 125591997

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveNAPROXEN SODIUM USP

DMF 141851999

MYLAN LABORATORIES LTDInactiveNAPROXEN SODIUM USP

DMF 157322001

VERA LABORATORIES LTDInactiveNAPROXEN SODIUM

DMF 162002002

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

Products (1)

#001 — EQ 200MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 4, 2019

No patent or exclusivity listings for this strength.