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Orange Book drug · Generic (ANDA)

Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate

Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate

ANDA 040422 7 strengths Barr
Approved
Feb 11, 2002
Strengths
7
Listed patents
0
Applications
41

What does the FDA Orange Book show for Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate?

Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate contains Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate across 41 FDA applications. ANDA 040422 is the lead filing; other filings are listed separately. This page preserves Orange Book facts and source limits. Clinical labeling requires an exact application-matched source.

FDA applications
41; lead ANDA 040422

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

Lead application holder
Barr Laboratories Inc

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

Product presentations
7

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
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
0011.25MG;1.25MG;1.25MG;1.25MGTABLETORALPrescriptionAB
None posted
0022.5MG;2.5MG;2.5MG;2.5MGTABLETORALPrescriptionAB
None posted
0035MG;5MG;5MG;5MGTABLETORALPrescriptionAB
None posted
0047.5MG;7.5MG;7.5MG;7.5MGTABLETORALPrescriptionAB
RS
0051.875MG;1.875MG;1.875MG;1.875MGTABLETORALPrescriptionAB
None posted
0063.125MG;3.125MG;3.125MG;3.125MGTABLETORALPrescriptionAB
None posted
0073.75MG;3.75MG;3.75MG;3.75MGTABLETORALPrescriptionAB
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

Barr Laboratories Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 040422.

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

7 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

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.

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 3 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 040422 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

Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate

23 applications
Product rows
149
Active applications
18
Active with AB row
18
Adderall 10 · NDA 011522

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-040422

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

7 approved presentations · ANDA 040422
TE AB
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    24 yr 10 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 040422

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

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 Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate

40 additional filings · 40 generic

The FDA has approved 41 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 Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 040439SandozSep 27, 20024ABPrescription
ANDA 040440Specgx LLCOct 07, 20037ABPrescription
ANDA 040444Epic Pharma LLCJun 19, 20027ABPrescription
ANDA 040456Actavis ElizabethMay 06, 20034—Discontinued
ANDA 040472Teva PharmsSep 30, 20034—Discontinued
ANDA 040480Sun Pharm IndustriesSep 09, 20037ABPrescription
ANDA 076536Barr Labs IncFeb 12, 20136—Discontinued
ANDA 076852Impax LabsFeb 16, 20166AB1Prescription
ANDA 077302Actavis ElizabethJun 22, 20126AB1Prescription
ANDA 077488TevaApr 29, 20136—Discontinued
ANDA 202424Aurolife Pharma LLCNov 27, 20137ABPrescription
ANDA 205401Ani PharmsJan 22, 20196AB1Prescription
ANDA 206159Ph HealthMay 31, 20196—Discontinued
ANDA 206340Actavis ElizabethFeb 05, 20167ABPrescription
ANDA 206721CorepharmaNov 10, 20157—Discontinued
ANDA 207340Zydus PharmsOct 31, 20177ABPrescription
ANDA 207388AlvogenJul 28, 20177ABPrescription
ANDA 209799Nuvo PharmDec 28, 20177ABPrescription
ANDA 210080Nesher PharmsJul 17, 20196—Discontinued
ANDA 210293OryzaApr 03, 20206ABPrescription
ANDA 210651Rhodes PharmsMay 17, 20196AB1Prescription
ANDA 210754Cediprof IncJul 05, 20225ABPrescription
ANDA 210876Teva Pharms USAJan 31, 20224AB2Prescription
ANDA 211352Elite Labs IncDec 07, 20187ABPrescription
ANDA 211546Specgx LLCAug 31, 20234AB2Prescription
ANDA 211547Specgx LLCApr 22, 20196AB1Prescription
ANDA 211715Sun Pharm IndustriesMay 17, 20196—Discontinued
ANDA 211876Aurolife Pharma LLCJun 24, 20206—Discontinued
ANDA 212037Elite Labs IncDec 11, 20196AB1Prescription
ANDA 213111Rhodes PharmsJan 13, 20217ABPrescription
ANDA 213709Ascent Pharms IncApr 22, 20217ABPrescription
ANDA 214347Accord HlthcareNov 22, 20217—Discontinued
ANDA 214403Lannett Co IncNov 26, 20216AB1Prescription
ANDA 214777LupinNov 07, 20246AB1Prescription
ANDA 214959Ascent Pharms IncSep 29, 20216AB1Prescription
ANDA 215565Lannett Co IncJul 08, 20227ABPrescription
ANDA 215771GranulesDec 28, 20217ABPrescription
ANDA 215997Sun Pharm Inds IncSep 27, 20234AB2Prescription
ANDA 217027GranulesJan 23, 20236AB1Prescription
ANDA 217787Alkem Labs LtdOct 06, 20237ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate

View full Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate 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.

Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate: 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 040422 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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