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Orange Book drug · Brand (NDA)

Cetirizine Hydrochloride Allergy

Cetirizine Hydrochloride

RLDNDA 022429 2 strengths Bionpharma
Approved
Jul 23, 2009
Strengths
2
Listed patents
0
Applications
28

What does the FDA Orange Book show for Cetirizine Hydrochloride Allergy?

Cetirizine Hydrochloride Allergy contains Cetirizine Hydrochloride and appears in 28 FDA Orange Book applications. NDA 022429 is the lead filing, with 2 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
28; lead NDA 022429

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Bionpharma Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Over-the-counter

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
0

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

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.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0015MGCAPSULEORALOver-the-counterNone posted
RLD
00410MGCAPSULEORALOver-the-counterNone posted
RLDRS

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

Bionpharma Inc

The Orange Book identifies this organization as the applicant responsible for NDA 022429.

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

2 presentations listed as over-the-counter

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

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

37 other ANDAs and 7 other NDAs found

25 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

NDA 022429 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Cetirizine Hydrochloride

5 applications
Product rows
9
Active applications
4
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-022429

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

2 approved presentations · NDA 022429
RLD
Strength
5MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Over-the-counter

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    17 yr 3 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

CETIRIZINE HYDROCHLORIDE

Strength

5MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 022429

Product number

001

Marketing status

Over-the-counter

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 Cetirizine Hydrochloride Allergy

27 additional filings · 27 generic

The FDA has approved 28 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 Cetirizine Hydrochloride Allergy, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 076047Contract PharmacalDec 27, 20072—Over-the-counter
ANDA 076677MylanDec 27, 20072—Over-the-counter
ANDA 077318Cipla LtdJul 25, 20132—Discontinued
ANDA 077498Sun Pharm Inds LtdDec 27, 20072—Over-the-counter
ANDA 077499Sun Pharm Inds IncDec 27, 20072—Discontinued
ANDA 077631Sun Pharm Inds IncJan 11, 20082—Discontinued
ANDA 077829UniqueAug 26, 20092—Over-the-counter
ANDA 077946Pld AcquisitionsDec 27, 20072—Over-the-counter
ANDA 078072TaroJul 22, 20092—Discontinued
ANDA 078317Apotex IncDec 27, 20072—Over-the-counter
ANDA 078336Perrigo R And DDec 27, 20072—Over-the-counter
ANDA 078343DR Reddys Labs LtdJan 15, 20082—Over-the-counter
ANDA 078427Glenmark PharmsDec 28, 20072—Over-the-counter
ANDA 078615Heritage PharmaDec 28, 20072—Discontinued
ANDA 078680UnichemJun 26, 20092—Discontinued
ANDA 078780Amneal Pharms NyJan 21, 20102—Discontinued
ANDA 078862Orbion PharmsFeb 19, 20092—Over-the-counter
ANDA 078933Marksans PharmaJun 15, 20102—Over-the-counter
ANDA 079191Torrent Pharms LLCApr 15, 20102—Discontinued
ANDA 090760Aurobindo Pharma LtdAug 05, 20152—Over-the-counter
ANDA 202277Aiping Pharm IncMar 11, 20142—Discontinued
ANDA 205291Onesource SpecialtyJul 21, 20171—Over-the-counter
ANDA 205490Perrigo R And DSep 02, 20151—Over-the-counter
ANDA 207235ApotexAug 12, 20161—Discontinued
ANDA 209107Aurobindo Pharma LtdJul 20, 20181—Over-the-counter
ANDA 209274GranulesDec 22, 20171—Over-the-counter
ANDA 213105CatalentSep 21, 20201—Over-the-counter

Active-ingredient family

Brand + generics

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

View full Cetirizine Hydrochloride 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.

Cetirizine Hydrochloride Allergy: frequently asked questions

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

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 022429 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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