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Orange Book product · Brand (NDA)

Aldactazide

Hydrochlorothiazide; Spironolactone

Brand (NDA)NDA 012616DiscontinuedRLD Pfizer
Approved
Dec 30, 1982
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Aldactazide (Hydrochlorothiazide; Spironolactone) is Pfizer's brand-name drug, approved by the FDA under NDA 012616 in 1982. 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 Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 17 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 30, 1982

    44 yr 2 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Strength

50MG;50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 012616

Product number

005

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 012616

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 Hydrochlorothiazide; Spironolactone family
Orange Book patent file

Listed patents

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.

Aldactazide — 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 Hydrochlorothiazide; Spironolactone active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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