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NOR-QD

NDA

NORETHINDRONE | N017060 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

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 Chain7 active DMFs9 inactive

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

DR REDDYS LABORATORIES LTDNORETHINDRONE

DMF 2401957

BAYER AGNORETHINDRONE

DMF 27261976

ASPEN OSS BVNORETHINDRONE

DMF 38491980

LUPIN LTDNORETHINDRONE USP

DMF 225052009

VALDEPHARMNORETHINDRONE

DMF 244162011

NAARI PTE LTDNORETHINDRONE

DMF 358032021

ARESKO LIFE SCIENCES PVT LTDNORETHINDRONE USP

DMF 422272025

ROUSSEL CORPInactiveNORETHINDRONE

DMF 19201972

MITSUBISHI CHEMICAL INDUSTRIES LTDInactiveNORETHINDRONE ACETATE, BULK

DMF 29841977

GEDEON RICHTER LTDInactiveNORETHINDRONE 1 MG. AND MESTRANOL 0.05 MG. TABLETS IN BULK

DMF 66391986

GEDEON RICHTER LTDInactiveNORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS.

DMF 66601986

GEDEON RICHTER LTDInactiveNORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035

DMF 73321988

GEDEON RICHTER LTDInactiveNORETHINDRONE 0.75 MG. AND ETHINYL ESTRADIOL 0.035 MG. TABLET

DMF 74661988

STOLLE RESEARCH AND DEVELOPMENT CORPInactiveNORETHINDRONE INJECTABLE MICROSPHERES - CINCINNATI, OHIO

DMF 75881988

ROUSSELL UCLAFInactiveNORETHINDRONE

DMF 82391989

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDInactiveNORETHINDRONE

DMF 241762010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 25, 2005	SUPPL -67	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.35MG

RLDAB1

0 patents0 exclusivities▴

TABLET;ORAL-28 | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.