Is WINDER LABORATORIES, LLC FDA approved?

WINDER LABORATORIES, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are WINDER LABORATORIES, LLC's drugs manufactured?

The FDA register lists WINDER, GA. Registered operations: finished drug manufacture.

What drugs does WINDER LABORATORIES, LLC make?

31 products are listed under WINDER LABORATORIES, LLC in the openFDA NDC Directory, most often as tablet; tablet, chewable; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

WINDER LABORATORIES, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 31
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
WINDER LABORATORIES, LLC	712 PATRICK INDUSTRIAL LANE, WINDER, Georgia (GA) 30680, United States (USA)	Finished drug manufacture	3008694072117649906

Catalogue

Drug listings by form and route

31 active NDC listings: 31 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 19, ANDA 12.

Dosage form	NDCs
tablet	19
tablet, chewable	6
solution	3
elixir	2
capsule	1

Route	NDCs
oral	31

Labeller name on the listing	NDCs
winder laboratories llc	14
winder laboratories, llc	14
winder laboratories, llc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Chlordiazepoxide Hydrochloride and Clidinium Bromide	Chlordiazepoxide Hydrochloride and Clidinium Bromide	capsule, oral	75826-134ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-120ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-121ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-122ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-123ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-124ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-125ANDA
Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	tablet, oral	75826-126ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	tablet, oral	75826-107ANDA
Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-163UNAPPROVED DRUG OTHER
Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-164UNAPPROVED DRUG OTHER
Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-165UNAPPROVED DRUG OTHER
Morphine Sulfate	Morphine Sulfate	solution, oral	75826-129ANDA
Morphine Sulfate	Morphine Sulfate	solution, oral	75826-130ANDA
Morphine Sulfate	Morphine Sulfate	solution, oral	75826-131ANDA
Multivitamin with Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-169UNAPPROVED DRUG OTHER
Multivitamin with Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-170UNAPPROVED DRUG OTHER
Multivitamin with Fluoride	Sodium Fluoride	tablet, chewable, oral	75826-171UNAPPROVED DRUG OTHER
Phenazopyridine Hydrochloride	Phenazopyridine Hydrochloride	tablet, oral	75826-114UNAPPROVED DRUG OTHER
Phenazopyridine Hydrochloride	Phenazopyridine Hydrochloride	tablet, oral	75826-115UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-136UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-137UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-138UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-139UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-140UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-141UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-142UNAPPROVED DRUG OTHER
Phenobarbital	Phenobarbital	tablet, oral	75826-143UNAPPROVED DRUG OTHER
Phenohytro	PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE	tablet, oral	75826-118UNAPPROVED DRUG OTHER
Phenohytro	Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide	elixir, oral	75826-127UNAPPROVED DRUG OTHER
Phenohytro	Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide	elixir, oral	75826-128UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is WINDER LABORATORIES, LLC FDA approved?: WINDER LABORATORIES, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are WINDER LABORATORIES, LLC's drugs manufactured?: The FDA register lists WINDER, GA. Registered operations: finished drug manufacture.
What drugs does WINDER LABORATORIES, LLC make?: 31 products are listed under WINDER LABORATORIES, LLC in the openFDA NDC Directory, most often as tablet; tablet, chewable; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.