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Orange Book drug · Generic (ANDA)

Oxycodone And Acetaminophen

Acetaminophen; Oxycodone Hydrochloride

ANDA 040608 4 strengths Mikart
Approved
Dec 30, 2005
Strengths
4
Listed patents
0
Applications
51

What does the FDA Orange Book show for Oxycodone And Acetaminophen?

Oxycodone And Acetaminophen contains Acetaminophen; Oxycodone Hydrochloride and appears in 51 FDA Orange Book applications. ANDA 040608 is the lead filing, with 4 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
51; lead ANDA 040608

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

Lead application holder
Mikart LLC

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

Product presentations
4

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
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
001300MG;2.5MGTABLETORALPrescriptionNone posted
RS
002300MG;5MGTABLETORALPrescriptionNone posted
RS
003300MG;7.5MGTABLETORALPrescriptionNone posted
RS
004300MG;10MGTABLETORALPrescriptionNone posted
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

Mikart LLC

The Orange Book identifies this organization as the applicant responsible for ANDA 040608.

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

4 presentations 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

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

13 other ANDAs and 1 other NDA found

2 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 040608 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

Acetaminophen; Oxycodone Hydrochloride

46 applications
Product rows
103
Active applications
18
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-040608

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

4 approved presentations · ANDA 040608
RS
Strength
300MG;2.5MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    20 yr 10 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Strength

300MG;2.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 040608

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 Oxycodone And Acetaminophen

50 additional filings · 50 generic

The FDA has approved 51 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 Oxycodone And Acetaminophen, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 211499Abhai LLCDec 31, 20181—Prescription
ANDA 040105Ph HealthJul 30, 19961—Discontinued
ANDA 040106Vintage PharmsJul 30, 19961—Discontinued
ANDA 040171Watson LabsOct 30, 19971—Discontinued
ANDA 040199Actavis ElizabethDec 30, 19981—Discontinued
ANDA 040203Actavis ElizabethMar 15, 19991—Discontinued
ANDA 040219Mutual PharmJan 22, 19981—Discontinued
ANDA 040234Watson LabsOct 30, 19971—Discontinued
ANDA 040257MallinckrodtAug 04, 19981—Discontinued
ANDA 040272Duramed Pharms BarrJun 30, 19981—Discontinued
ANDA 040289Duramed Pharms BarrMar 16, 19991—Discontinued
ANDA 040303Vintage Pharms LLCDec 30, 19991—Discontinued
ANDA 040304BarrOct 02, 20001—Discontinued
ANDA 040371Watson LabsDec 29, 20002—Discontinued
ANDA 040535Watson LabsSep 05, 20032—Discontinued
ANDA 040545Specgx LLCJun 30, 20042AAPrescription
ANDA 040550MallinckrodtJun 30, 20042—Discontinued
ANDA 040676MikartApr 19, 20061—Discontinued
ANDA 040679MikartMay 16, 20061—Discontinued
ANDA 040680Specgx LLCSep 29, 20061—Discontinued
ANDA 040687MikartApr 27, 20061—Discontinued
ANDA 040692MikartApr 27, 20061—Discontinued
ANDA 040698MikartApr 27, 20061—Discontinued
ANDA 040777Amneal PharmsNov 27, 20071AAPrescription
ANDA 040778Amneal Pharms NyJun 27, 20142AAPrescription
ANDA 040789Amneal Pharms NyNov 27, 20072—Discontinued
ANDA 040800Actavis ElizabethApr 03, 20122—Discontinued
ANDA 087406BarrApproved Prior to Jan 1, 19821—Discontinued
ANDA 089994HalseyMay 04, 19891—Discontinued
ANDA 090177DR Reddys Labs SaOct 20, 20086—Discontinued
ANDA 090535Sun Pharm Inds IncDec 26, 20134—Discontinued
ANDA 090733Ph HealthJul 11, 20131—Discontinued
ANDA 090734Ph HealthJul 11, 20132—Discontinued
ANDA 201278Rhodes PharmsAug 28, 20143AAPrescription
ANDA 201447Actavis ElizabethApr 12, 20134AAPrescription
ANDA 201448Sankalp LifecareAug 26, 20211—Discontinued
ANDA 201972Aurolife Pharma LLCJul 15, 20134AAPrescription
ANDA 202142MikartNov 27, 20181—Prescription
ANDA 202677AlvogenMar 08, 20163AAPrescription
ANDA 203864Epic Pharma LLCJul 02, 20183AAPrescription
ANDA 204407Novel Labs IncFeb 24, 20174AAPrescription
ANDA 207333Lannett Co IncSep 25, 20172AAPrescription
ANDA 207419Ascent Pharms IncMar 22, 20174AAPrescription
ANDA 207510Wes Pharma IncMar 21, 20183AAPrescription
ANDA 207574SanaluzDec 13, 20161—Discontinued
ANDA 207834ChartwellAug 15, 20193—Discontinued
ANDA 209385Elite Labs IncJul 02, 20183AAPrescription
ANDA 210079Nesher PharmsDec 28, 20174—Discontinued
ANDA 210644Abhai LLCFeb 09, 20184AAPrescription
ANDA 211708GranulesOct 31, 20194AAPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Acetaminophen; Oxycodone Hydrochloride

View full Acetaminophen; Oxycodone 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.

Oxycodone And Acetaminophen: 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 040608 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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