Is Edwards Pharmaceuticals, Inc. FDA approved?

Edwards Pharmaceuticals, Inc. 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 Edwards Pharmaceuticals, Inc.'s registered sites?

The FDA register lists Paoli, PA. Registered operations: labelling.

What drugs does Edwards Pharmaceuticals, Inc. make?

12 products are listed under Edwards Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as liquid; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Edwards Pharmaceuticals, Inc.

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

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Registered sites: 1
Active NDC listings: 12
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Edwards Pharmaceuticals, Inc.	3Paoli Plaza, Suite C, Paoli, Pennsylvania (PA) 19301, United States (USA)	Labelling	1020025195118880

Catalogue

Drug listings by form and route

12 active NDC listings: 11 human otc drug, 1 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 7, OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
liquid	8
tablet, coated	4

Route	NDCs
oral	12

Labeller name on the listing	NDCs
edwards pharmaceuticals, inc.	10
edwards pharmaceuticals, inc	1
edwards pharmaceuticals, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ED A-HIST	Chlorpheniramine/Phenylephrine	liquid, oral	0485-0155UNAPPROVED DRUG OTHER
ED A-HIST	CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE	tablet, coated, oral	0485-0254UNAPPROVED DRUG OTHER
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE	liquid, oral	0485-0171OTC MONOGRAPH DRUG
ED APAP	ACETAMINOPHEN	liquid, oral	0485-0057OTC MONOGRAPH DRUG
ED BRON GP	GUAIFENESIN and PHENYLEPHRINE	liquid, oral	0485-0208UNAPPROVED DRUG OTHER
ED CHLORPED JR	CHLORPHENIRAMINE MALEATE	liquid, oral	0485-0098UNAPPROVED DRUG OTHER
ED-A-HIST DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE	tablet, coated, oral	0485-0240UNAPPROVED DRUG OTHER
RYMED	DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE	tablet, coated, oral	0485-0080OTC MONOGRAPH DRUG
RYNEX PE	BROMPHENIRAMINE MALEATE and Phenylephrine HCL	liquid, oral	0485-0202OTC MONOGRAPH DRUG
RYNEX PSE	BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE	liquid, oral	0485-0206UNAPPROVED DRUG OTHER
Rynex DM	Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride	liquid, oral	0485-0204OTC MONOGRAPH DRUG
UROGESIC BLUE	METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE	tablet, coated, oral	0485-0151UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

EDW PHARMA, INC.Paoli, PA
Womens Choice Pharmaceuticals, IncPaoli, PA

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Enquiry

Common questions

Is Edwards Pharmaceuticals, Inc. FDA approved?: Edwards Pharmaceuticals, Inc. 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 Edwards Pharmaceuticals, Inc.'s registered sites?: The FDA register lists Paoli, PA. Registered operations: labelling.
What drugs does Edwards Pharmaceuticals, Inc. make?: 12 products are listed under Edwards Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as liquid; tablet, coated. 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.