Viewing data from:

LUNELLE

NDA

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE | N020874 | PHARMACIA AND UPJOHN 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Sarah A. Norring FDA-2024-P-2952 · 7 docket documents Sarah A. Norring submitted this citizen petition under 21 CFR 10.30 and 21 CFR 314.161 requesting the FDA Commissioner determine whether Lunelle (estradiol cypionate 5mg/0.5ml and medroxyprogesterone acetate 25mg/0.5ml intramuscular injectable), approved under NDA 020874 in October 2000, was withdra	Other	2024-06-21	Granted	Sarah A. Norring

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 5, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/0.5ML;25MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR | Approved: Oct 5, 2000

No patent or exclusivity listings for this strength.