Skip to content
Assyro AI
Orange Book drug · Generic (ANDA)

Haloperidol

Haloperidol

ANDA 070278 6 strengths Mylan
Approved
Jun 10, 1986
Strengths
6
Listed patents
0
Applications
95

What does the FDA Orange Book show for Haloperidol?

Haloperidol contains Haloperidol and appears in 95 FDA Orange Book applications. ANDA 070278 is the lead filing, with 6 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
95; lead ANDA 070278

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

Lead application holder
Mylan Pharmaceuticals Inc

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

Product presentations
6

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

Marketing categories
Prescription and Discontinued

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
AB

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
0012MGTABLETORALPrescriptionAB
RS
00210MGTABLETORALPrescriptionAB
None posted
00320MGTABLETORALDiscontinuedNone posted
None posted
0041MGTABLETORALPrescriptionAB
None posted
0055MGTABLETORALPrescriptionAB
None posted
0060.5MGTABLETORALPrescriptionAB
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

Mylan Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 070278.

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: 5 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 2 other NDAs 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 070278 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-070278

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

6 approved presentations · ANDA 070278
TE ABRS
Strength
2MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    40 yr 9 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

HALOPERIDOL

Strength

2MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 070278

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 Haloperidol

94 additional filings · 94 generic

The FDA has approved 95 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 Haloperidol, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 073037Pharm AssocFeb 26, 19931AAPrescription
ANDA 078347Mylan Labs LtdSep 14, 20091APPrescription
ANDA 070318AlpharmaApr 11, 19861—Discontinued
ANDA 070710Morton GroveMar 07, 19861—Discontinued
ANDA 070713Watson LabsMay 17, 19881—Discontinued
ANDA 070714Watson LabsMay 17, 19881—Discontinued
ANDA 070720ScsJun 10, 19861—Discontinued
ANDA 070721ScsJun 10, 19861—Discontinued
ANDA 070722ScsJun 10, 19861—Discontinued
ANDA 070723ScsJun 10, 19861—Discontinued
ANDA 070724ScsJun 10, 19861—Discontinued
ANDA 070725ScsSep 24, 19861—Discontinued
ANDA 070726ScsJun 10, 19861—Discontinued
ANDA 070744Watson LabsMay 17, 19881—Discontinued
ANDA 070800SolopakDec 14, 19871—Discontinued
ANDA 070801SolopakDec 14, 19871—Discontinued
ANDA 070802Smith And NephewDec 14, 19871—Discontinued
ANDA 070864SolopakDec 14, 19871—Discontinued
ANDA 070981Watson LabsMar 06, 19871—Discontinued
ANDA 070982Watson LabsMar 06, 19871—Discontinued
ANDA 070983Watson LabsMar 06, 19871—Discontinued
ANDA 070984Watson LabsMar 06, 19871—Discontinued
ANDA 071015TevaAug 25, 19871—Discontinued
ANDA 071071Purepac PharmNov 03, 19861—Discontinued
ANDA 071072Purepac PharmNov 03, 19861—Discontinued
ANDA 071073Purepac PharmNov 03, 19861—Discontinued
ANDA 071074Purepac PharmNov 03, 19861—Discontinued
ANDA 071075Purepac PharmAug 04, 19871—Discontinued
ANDA 071076Purepac PharmAug 04, 19871—Discontinued
ANDA 071128Aiping Pharm IncFeb 17, 19871—Discontinued
ANDA 071129Aiping Pharm IncFeb 17, 19871—Discontinued
ANDA 071130Aiping Pharm IncApr 08, 20266ABPrescription
ANDA 071133Aiping Pharm IncMay 12, 19871—Discontinued
ANDA 071173InnogenixJan 02, 19876ABPrescription
ANDA 071187Abraxis PharmJan 20, 19871—Discontinued
ANDA 071209Chartwell RxNov 17, 19864ABPrescription
ANDA 071210Chartwell RxMar 11, 19881ABPrescription
ANDA 071211Chartwell RxMar 11, 19881ABPrescription
ANDA 071216Duramed Pharms BarrDec 04, 19861—Discontinued
ANDA 071217Duramed Pharms BarrDec 04, 19861—Discontinued
ANDA 071218Duramed Pharms BarrDec 04, 19861—Discontinued
ANDA 071219Duramed Pharms BarrDec 04, 19861—Discontinued
ANDA 071220Duramed Pharms BarrJul 07, 19871—Discontinued
ANDA 071221Duramed Pharms BarrJul 07, 19871—Discontinued
ANDA 071235Strides Pharma IntlNov 03, 19865—Discontinued
ANDA 071255Quantum PharmicsFeb 17, 19871—Discontinued
ANDA 071256Quantum PharmicsFeb 17, 19871—Discontinued
ANDA 071257Quantum PharmicsFeb 17, 19871—Discontinued
ANDA 071269Quantum PharmicsFeb 17, 19871—Discontinued
ANDA 071328Par PharmJul 20, 19871—Discontinued
ANDA 071374Watson LabsJun 03, 19881—Discontinued
ANDA 071375Watson LabsJun 03, 19881—Discontinued
ANDA 071376Watson LabsJun 03, 19881—Discontinued
ANDA 071571Watson LabsJun 03, 19881—Discontinued
ANDA 071572Watson LabsJun 03, 19881—Discontinued
ANDA 071573Watson LabsJun 03, 19881—Discontinued
ANDA 071617Teva PharmsDec 01, 19881—Discontinued
ANDA 071722Royce LabsDec 24, 19871—Discontinued
ANDA 071723Royce LabsDec 24, 19871—Discontinued
ANDA 071724Royce LabsDec 24, 19871—Discontinued
ANDA 071725Royce LabsDec 24, 19871—Discontinued
ANDA 072113Watson LabsAug 27, 19911—Discontinued
ANDA 072121Royce LabsDec 24, 19871—Discontinued
ANDA 072122Royce LabsDec 24, 19871—Discontinued
ANDA 072353Watson LabsAug 27, 19911—Discontinued
ANDA 072516Marsam Pharms LLCFeb 25, 19931—Discontinued
ANDA 072517Marsam Pharms LLCFeb 25, 19931—Discontinued
ANDA 072727LederleSep 19, 19891—Discontinued
ANDA 072728LederleSep 19, 19891—Discontinued
ANDA 072729LederleSep 19, 19891—Discontinued
ANDA 072730LederleSep 19, 19891—Discontinued
ANDA 072731LederleSep 19, 19891—Discontinued
ANDA 072732LederleSep 19, 19891—Discontinued
ANDA 073364Lannett Co IncSep 28, 19931AAPrescription
ANDA 075689Fresenius Kabi USAMar 09, 20011APPrescription
ANDA 075858HikmaJun 18, 20011APPrescription
ANDA 076035Teva Pharms USAAug 29, 20011—Discontinued
ANDA 076464Fosun PharmaSep 29, 20041—Discontinued
ANDA 076774Gland Pharma LtdAug 25, 20041—Discontinued
ANDA 076791Baxter Hlthcare CorpAug 25, 20041—Discontinued
ANDA 076828Baxter Hlthcare CorpAug 25, 20041—Discontinued
ANDA 077580Zydus Pharms USAJan 17, 20236ABPrescription
ANDA 091637Sagent PharmsSep 02, 20111APPrescription
ANDA 200742Sagent PharmsSep 02, 20111APPrescription
ANDA 200854Actavis GroupJul 01, 20226—Discontinued
ANDA 204849Epic Pharma LLCSep 06, 20171—Discontinued
ANDA 210356Fresenius Kabi USAJul 01, 20191—Discontinued
ANDA 211061AppcoJan 08, 20206ABPrescription
ANDA 214470AlembicJun 04, 20265ABPrescription
ANDA 216004MsnNov 18, 20226ABPrescription
ANDA 216918Mankind PharmaApr 11, 20246ABPrescription
ANDA 218162Creekwood PharmsDec 18, 20256ABPrescription
ANDA 218371Rubicon ResearchJan 31, 20241AAPrescription
ANDA 218789Aurobindo Pharma LtdApr 19, 20246ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Haloperidol

View full Haloperidol 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.

Haloperidol: 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 070278 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo