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SOLAGE

NDA

MEQUINOL; TRETINOIN | N020922 | ALMIRALL LLC

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
Citizens Petition from Jerussi Consulting, Inc. FDA-2003-P-0015 · 8 docket documents Jerussi Consulting, Inc. filed this suitability petition on August 11, 2003, requesting that the FDA determine that a topical solution containing 4% hydroquinone and 0.01% tretinoin can be substituted for the approved formulation of Solage (NDA #20-922), which contains 2% mequinol and 0.01% tretinoi	Other	2009-04-10	Denied	Jerussi Consulting, Inc.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%;0.01%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 10, 1999

No patent or exclusivity listings for this strength.