Is ESTEVE PHARMACEUTICALS, S.A. FDA approved?

ESTEVE PHARMACEUTICALS, S.A. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does ESTEVE PHARMACEUTICALS, S.A. make?

8 products are listed under ESTEVE PHARMACEUTICALS, S.A. in the openFDA NDC Directory, most often as injection, solution; injection; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Are any ESTEVE PHARMACEUTICALS, S.A. products in shortage?

1 presentation is currently listed in the FDA drug shortage database under ESTEVE PHARMACEUTICALS, S.A., covering Streptozocin Powder, For Solution.

ESTEVE PHARMACEUTICALS, S.A.

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

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Registered sites: 0
Active NDC listings: 8
Live patents: 5
Shortage listings: 1
Countries: 0

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Streptozocin Powder, For SolutionOncology	Zanosar, Powder, For Solution, 1 g/10 mL (NDC 68118-100-01)	Current	Available	12 Jul 202216 Sept 2026

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: NDA 7, UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 1.

Dosage form	NDCs
injection, solution	3
injection	2
capsule, gelatin coated	1
powder, for solution	1
tablet	1

Route	NDCs
intrathecal	3
intravenous	3
oral	2

Labeller name on the listing	NDCs
esteve pharmaceuticals, s.a.	8

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8513259	QUZYTTIRcetirizine hydrochloride	use	Feb 2030
9119771	QUZYTTIRcetirizine hydrochloride	use	Feb 2030
9180090	QUZYTTIRcetirizine hydrochloride	use	Feb 2030
8263581	QUZYTTIRcetirizine hydrochloride	use	Feb 2030
8314083	QUZYTTIRcetirizine hydrochloride	use	Feb 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Lysodren	mitotane	tablet, oral	68118-080NDA
Metopirone	Metyrapone	capsule, gelatin coated, oral	68118-455NDA
PRIALT	ziconotide acetate	injection, solution, intrathecal	68118-720NDA
PRIALT	ziconotide acetate	injection, solution, intrathecal	68118-722NDA
PRIALT	ziconotide acetate	injection, solution, intrathecal	68118-723NDA
QUZYTTIR	Cetirizine Hydrochloride	injection, intravenous	68118-100NDA
QUZYTTIR	Cetirizine Hydrochloride	injection, intravenous	68118-200NDA
Zanosar	Streptozocin	powder, for solution, intravenous	68118-500UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

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Enquiry

Common questions

Is ESTEVE PHARMACEUTICALS, S.A. FDA approved?: ESTEVE PHARMACEUTICALS, S.A. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does ESTEVE PHARMACEUTICALS, S.A. make?: 8 products are listed under ESTEVE PHARMACEUTICALS, S.A. in the openFDA NDC Directory, most often as injection, solution; injection; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any ESTEVE PHARMACEUTICALS, S.A. products in shortage?: 1 presentation is currently listed in the FDA drug shortage database under ESTEVE PHARMACEUTICALS, S.A., covering Streptozocin Powder, For Solution.

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.