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NORLUTATE

NDA

NORETHINDRONE ACETATE | N012184 | PARKE DAVIS DIV WARNER LAMBERT CO

1 strength0 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 Chain5 active DMFs3 inactive

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

BAYER AGNORETHINDRONE ACETATE

DMF 20331972

ASPEN OSS BVNORETHINDRONE ACETATE

DMF 101851993

LUPIN LTDNORETHINDRONE ACETATE USP

DMF 225072009

VALDEPHARMNORETHINDRONE ACETATE

DMF 249132011

NAARI PTE LTDNORETHINDRONE ACETATE

DMF 360632021

SYNTEX USA INCInactiveNORETHINDRONE ACETATE

DMF 10841967

ROUSSEL CORPInactiveNORETHINDRONE ACETATE

DMF 18461971

NOVO NORDISK ASInactiveNORETHINDRONE ACETATE

DMF 63531986

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

Products (1)

#002 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.