Is Apresoline still available?

Apresoline (NDA 008303) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Apresoline have a generic?

Yes. The Orange Book lists 50 approved generic (ANDA) applications sharing Apresoline's active ingredient (Hydralazine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Apresoline's FDA application number?

Apresoline is approved under NDA 008303, held by Novartis.

Orange Book product · Brand (NDA)

Apresoline

Hydralazine Hydrochloride

Brand (NDA)NDA 008303DiscontinuedRLD Novartis

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Apresoline (Hydralazine Hydrochloride) is Novartis's brand-name drug, approved by the FDA under NDA 008303. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 50 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

HYDRALAZINE HYDROCHLORIDE

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 008303

Product number

005

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 008303

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Hydralazine Hydrochloride family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Apresoline — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Hydralazine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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