Is APOZEAL PHARMACEUTICALS INC FDA approved?

APOZEAL 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 APOZEAL PHARMACEUTICALS INC's drugs manufactured?

The FDA register lists Levittown, PA. Registered operations: analytical testing, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does APOZEAL PHARMACEUTICALS INC make?

7 products are listed under APOZEAL PHARMACEUTICALS INC in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

APOZEAL PHARMACEUTICALS INC

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

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Registered sites: 1
Active NDC listings: 7
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
APOZEAL PHARMACEUTICALS INC	2091 Hartel St, Levittown, Pennsylvania (PA) 19057, United States (USA)	Analytical testing, Finished drug manufacture, Packaging, Relabelling, Repackaging	3004536846119101193

Catalogue

Drug listings by form and route

7 active NDC listings: 6 human prescription drug, 1 human otc drug. By marketing category: ANDA 7.

Dosage form	NDCs
solution	7

Route	NDCs
oral	7
rectal	1

Labeller name on the listing	NDCs
apozeal pharmaceuticals inc	6
apozeal pharmaceuticals inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Aminocaproic Acid	Aminocaproic Acid	solution, oral	83745-294ANDA
Cetirizine Hydrochloride Oral Solution	Cetirizine Hydrochloride Oral Solution	solution, oral	83745-185ANDA
Cetrizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	solution, oral	83745-188ANDA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	solution, oral	83745-232ANDA
Lactulose	Lactulose	solution, oral, rectal	83745-249ANDA
Lactulose	Lactulose	solution, oral	83745-405ANDA
Risperidone	Risperidone	solution, oral	83745-186ANDA

Neighbours

Registered in the same town

Home HealthworksLevittown, PA

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Enquiry

Common questions

Is APOZEAL PHARMACEUTICALS INC FDA approved?: APOZEAL 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 APOZEAL PHARMACEUTICALS INC's drugs manufactured?: The FDA register lists Levittown, PA. Registered operations: analytical testing, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does APOZEAL PHARMACEUTICALS INC make?: 7 products are listed under APOZEAL PHARMACEUTICALS INC in the openFDA NDC Directory, most often as 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.