Orange Book drug · Generic (ANDA)

Bisoprolol Fumarate And Hydrochlorothiazide

Bisoprolol Fumarate; Hydrochlorothiazide

DiscontinuedANDA 075469 3 strengths Watson Labs Teva

Approved

Sep 25, 2000

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Bisoprolol Fumarate And Hydrochlorothiazide?

Bisoprolol Fumarate And Hydrochlorothiazide contains Bisoprolol Fumarate; Hydrochlorothiazide and appears in 15 FDA Orange Book applications. ANDA 075469 is the lead filing, with 3 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications: 15; lead ANDA 075469
Lead application holder: Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc
Product presentations: 3
Marketing categories: Discontinued
Reference roles: None posted
TE codes: None posted
Listed patents: 0
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	2.5MG;6.25MG	TABLETORAL	Discontinued	None posted	None posted
002	5MG;6.25MG	TABLETORAL	Discontinued	None posted	None posted
003	10MG;6.25MG	TABLETORAL	Discontinued	None posted	None posted

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 075469.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

3 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 075469 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Bisoprolol Fumarate; Hydrochlorothiazide

16 applications

Product rows: 48
Active applications: 10
Active with AB row: 10

Ziac · NDA 020186

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-075469

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

3 approved presentations · ANDA 075469

Discontinued

Strength: 2.5MG;6.25MG
Dosage form: TABLET
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 25, 2000
26 yr 3 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Strength

2.5MG;6.25MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 075469

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Listed patents

Orange Book patent file

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.

Other FDA applications for Bisoprolol Fumarate And Hydrochlorothiazide

14 additional filings · 14 generic

The FDA has approved 15 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Bisoprolol Fumarate And Hydrochlorothiazide, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 075527	Chartwell Rx	Sep 25, 2000	3	—	Discontinued
ANDA 075579	Epic Pharma LLC	Sep 25, 2000	3	AB	Prescription
ANDA 075632	Ivax Sub Teva Pharms	Sep 27, 2000	3	—	Discontinued
ANDA 075642	Apothecon	Dec 27, 2000	3	—	Discontinued
ANDA 075672	Actavis Elizabeth	Sep 25, 2000	3	—	Discontinued
ANDA 075686	Teva	Jan 19, 2001	3	—	Discontinued
ANDA 075768	Mylan	Sep 25, 2000	3	AB	Prescription
ANDA 079106	Unichem	Jul 28, 2010	3	AB	Prescription
ANDA 212678	Edenbridge Pharms	Jul 09, 2020	3	AB	Prescription
ANDA 215562	Novitium Pharma	Nov 04, 2021	3	AB	Prescription
ANDA 215666	Cadila	Nov 04, 2022	3	AB	Prescription
ANDA 215995	Glenmark Pharms Ltd	Jan 26, 2022	3	AB	Prescription
ANDA 217922	Aurobindo Pharma Ltd	Jan 21, 2026	3	AB	Prescription
ANDA 219489	Unique Pharm	Mar 24, 2026	3	AB	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Bisoprolol Fumarate; Hydrochlorothiazide

ZiacBrand (NDA)
NDA 020186 · Teva Branded Pharm
1993

View full Bisoprolol Fumarate; Hydrochlorothiazide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.