Orange Book drug · Generic (ANDA)

Irbesartan And Hydrochlorothiazide

Hydrochlorothiazide; Irbesartan

ANDA 077369 3 strengths Teva

Approved

Mar 30, 2012

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Irbesartan And Hydrochlorothiazide?

Irbesartan And Hydrochlorothiazide contains Hydrochlorothiazide; Irbesartan and appears in 15 FDA Orange Book applications. ANDA 077369 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 077369
Lead application holder: Teva Pharmaceuticals USA Inc
Product presentations: 3
Marketing categories: Prescription and Discontinued
Reference roles: None posted
TE codes: AB
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	12.5MG;150MG	TABLETORAL	Prescription	AB	None posted
002	12.5MG;300MG	TABLETORAL	Prescription	AB	None posted
003	25MG;300MG	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

Teva Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 077369.

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

Status varies by presentation: 2 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 1 presentation in the application has no posted TE 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 077369 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

Hydrochlorothiazide; Irbesartan

16 applications

Product rows: 40
Active applications: 10
Active with AB row: 10

Avalide · NDA 020758

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-077369

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 077369

TE AB

Strength: 12.5MG;150MG
Dosage form: TABLET
Route: ORAL
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Mar 30, 2012
14 yr 6 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Strength

12.5MG;150MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 077369

Product number

001

Marketing status

Prescription

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 Irbesartan 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 Irbesartan And Hydrochlorothiazide, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 077446	Sandoz	Sep 27, 2012	2	AB	Prescription
ANDA 077969	Pharmobedient	Sep 27, 2012	3	—	Discontinued
ANDA 090351	Hikma	Oct 15, 2012	3	AB	Prescription
ANDA 091370	Alembic	Oct 15, 2012	3	AB	Prescription
ANDA 091539	Watson Labs Inc	Oct 22, 2012	2	—	Discontinued
ANDA 201505	Apotex Inc	Oct 15, 2012	2	—	Discontinued
ANDA 201524	Chartwell Rx	Feb 27, 2013	2	—	Discontinued
ANDA 202414	Macleods Pharms Ltd	Sep 27, 2012	2	AB	Prescription
ANDA 203036	Atlas Pharms LLC	Jan 15, 2016	3	—	Discontinued
ANDA 203072	Prinston Inc	May 09, 2014	2	AB	Prescription
ANDA 203500	DR Reddys Labs Ltd	Sep 27, 2012	2	AB	Prescription
ANDA 203630	Aurobindo Pharma Ltd	Feb 22, 2013	3	AB	Prescription
ANDA 207018	Unichem	Sep 19, 2017	2	—	Discontinued
ANDA 207896	Hisun Pharm Hangzhou	Oct 14, 2016	2	AB	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Hydrochlorothiazide; Irbesartan

AvalideBrand (NDA)
NDA 020758 · Sanofi Aventis US
1997

View full Hydrochlorothiazide; Irbesartan 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.