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Orange Book drug · Generic (ANDA)

Ondansetron Hydrochloride Preservative Free

Ondansetron Hydrochloride

ANDA 078287 Baxter Hlthcare Corp
Approved
Feb 22, 2013
Strengths
1
Listed patents
0
Applications
20

What does the FDA Orange Book show for Ondansetron Hydrochloride Preservative Free?

Ondansetron Hydrochloride Preservative Free contains Ondansetron Hydrochloride and appears in 20 FDA Orange Book applications. ANDA 078287 is the lead filing, with 1 presentation 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
20; lead ANDA 078287

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

Lead application holder
Baxter Healthcare Corp

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

Product presentations
1

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

Marketing categories
Prescription

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

Reference roles
RS

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

TE codes
AP

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
001EQ 2MG BASE/MLINJECTABLEINJECTIONPrescriptionAP
RS

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

Baxter Healthcare Corp

The Orange Book identifies this organization as the applicant responsible for ANDA 078287.

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

1 presentation listed as prescription

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

TE code AP across rated presentations

An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

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

48 other ANDAs and 4 other NDAs found

21 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 078287 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-078287

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.

Product detail

ANDA 078287
TE APRS
Strength
EQ 2MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 7 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ONDANSETRON HYDROCHLORIDE

Strength

EQ 2MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 078287

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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 Ondansetron Hydrochloride Preservative Free

19 additional filings · 19 generic

The FDA has approved 20 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 Ondansetron Hydrochloride Preservative Free, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 076696HospiraDec 26, 20061—Discontinued
ANDA 076759TevaNov 22, 20061—Discontinued
ANDA 076780Hikma FarmaceuticaDec 26, 20061—Discontinued
ANDA 076972Fresenius Kabi USADec 26, 20061APPrescription
ANDA 077011HikmaDec 26, 20061APPrescription
ANDA 077173Sun Pharm Inds LtdDec 26, 20061—Discontinued
ANDA 077343Apotex IncDec 26, 20061—Discontinued
ANDA 077387Am RegentDec 26, 20061—Discontinued
ANDA 077541HikmaDec 26, 20061APPrescription
ANDA 077548HospiraDec 26, 20061APPrescription
ANDA 077551SandozJun 27, 20071APPrescription
ANDA 077716Wockhardt Bio AgDec 26, 20061APPrescription
ANDA 078014Taro Pharms IrelandMar 21, 20081—Discontinued
ANDA 078244Onesource SpecialtyApr 23, 20081—Discontinued
ANDA 078945Avet LifesciencesJan 03, 20131—Discontinued
ANDA 079032Am RegentNov 18, 20081—Discontinued
ANDA 202253Fresenius Kabi USAJul 19, 20131APPrescription
ANDA 202600Eugia PharmaDec 21, 20121—Discontinued
ANDA 206845Accord HlthcareMar 10, 20161—Discontinued

Active-ingredient family

Brand + generics

Generic (ANDA) of Ondansetron Hydrochloride

View full Ondansetron 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.

Ondansetron Hydrochloride Preservative Free: 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 ANDA 078287 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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