Labeler · US market

Fougera Pharmaceuticals, LLC

Fougera Pharmaceuticals, LLC is a US drug labeler with US FDA registrations covering 6 drug concepts (6 currently active) across 8 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Fougera Pharmaceuticals Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes0168

Active drugs6

Registrations6 active / 6

Packages8

Sole supplier of1 drugs

Portfolio6 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Amcinonide cream	rx	1	3	SUPPLYING
Lidocaine ointment	rx	1	1	SUPPLYING
Swim-Ear solution	otc	1	1	SUPPLYING
Metronidazole cream	rx	1	1	SUPPLYING
Fluocinolone Acetonide solution	rx	1	1	SUPPLYING
Metronidazole lotion	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Swim-Earotc

At a glance

TypeLabeler
Labeler codes0168
Filing names2
Drugs (active)6
Drugs (all time)6
US registrations6
Packages8

Recent events

Shortages, recalls, and registration changes across all filing names.

Mar 2, 2017
RECALLRecall (Class II): Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.,…
Aug 28, 2014
RECALLRecall (Class II): FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET…
Jul 3, 2014
RECALLRecall (Class III): Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E…
Jul 3, 2014
RECALLRecall (Class III): Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. …
Jan 29, 2014
RECALLRecall (Class III): Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pha…
Nov 18, 2013
RECALLRecall (Class III): KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, …
Jul 18, 2012
RECALLRecall (Class III): Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals …
Jun 7, 2012
RECALLRecall (Class III): Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera P…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.