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FEMTRACE

NDA

ESTRADIOL ACETATE | N021633 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

3 strengths0 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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 14, 2014	SUPPL -5	View Letter (PDF)
Aug 25, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.45MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 20, 2004

No patent or exclusivity listings for this strength.

#002 — 0.9MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 20, 2004

#003 — 1.8MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 20, 2004