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Orange Book drug · Generic (ANDA)

Erythromycin

Erythromycin

ANDA 063038 Padagis US
Approved
Jan 11, 1991
Strengths
1
Listed patents
0
Applications
42

What does the FDA Orange Book show for Erythromycin?

Erythromycin contains Erythromycin and appears in 42 FDA Orange Book applications. ANDA 063038 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
42; lead ANDA 063038

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

Lead application holder
Padagis US LLC

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
AT

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
0012%SOLUTIONTOPICALPrescriptionAT
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

Padagis US LLC

The Orange Book identifies this organization as the applicant responsible for ANDA 063038.

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 AT across rated presentations

An AT 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

25 other ANDAs and 8 other NDAs 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 063038 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-063038

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 063038
TE ATRS
Strength
2%
Dosage form
SOLUTION
Route
TOPICAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    36 yr 1 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ERYTHROMYCIN

Strength

2%

Dosage form

SOLUTION

Route

TOPICAL

TE code

AT

Application

ANDA 063038

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 Erythromycin

41 additional filings · 39 generic

The FDA has approved 42 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 Erythromycin, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 063211Padagis USJan 29, 19931ATPrescription
ANDA 064067Bausch And Lomb IncJul 29, 19941ATPrescription
ANDA 064126Padagis USJul 03, 19961ATPrescription
ANDA 213628Cadila Pharms LtdJun 28, 20212ABPrescription
NDA 050532LillyApproved Prior to Jan 1, 19821—Discontinued
NDA 050610Paddock LLCNov 07, 19861—Discontinued
ANDA 061621CarnegieApproved Prior to Jan 1, 19822ABPrescription
ANDA 062326Alpharma US PharmsApr 19, 19821—Discontinued
ANDA 062327Alpharma US PharmsApr 19, 19821—Discontinued
ANDA 062328Alpharma US PharmsApr 19, 19821—Discontinued
ANDA 062342Alpharma US PharmsFeb 25, 19821—Discontinued
ANDA 062446PharmadermSep 26, 19831—Discontinued
ANDA 062447Padagis USSep 26, 19831—Discontinued
ANDA 062481PharmafairApr 05, 19841—Discontinued
ANDA 062485PharmafairJul 11, 19841—Discontinued
ANDA 062563Elkins SinnMar 28, 19852—Discontinued
ANDA 062616PharmafairJul 25, 19851—Discontinued
ANDA 062746CarnegieDec 22, 19861ABPrescription
ANDA 062825Pharmobedient CnsltgOct 23, 19871—Discontinued
ANDA 062957Alpharma US PharmsJul 21, 19881—Discontinued
ANDA 063098BarrMay 04, 19891—Discontinued
ANDA 064030SentissJul 18, 19961ATPrescription
ANDA 064039BauschJan 27, 19941—Discontinued
ANDA 064127Renaissance PharmaFeb 14, 19971—Discontinued
ANDA 064128PharmobedientJul 03, 19961—Discontinued
ANDA 064184Fougera PharmsSep 30, 19971ATPrescription
ANDA 064187Fougera PharmsSep 30, 19971—Discontinued
ANDA 065320Fougera PharmsJul 25, 20061—Discontinued
ANDA 090215Epic Pharma LLCMay 12, 20101ATPrescription
ANDA 208100EncubeNov 20, 20171—Discontinued
ANDA 208154EncubeJul 19, 20171—Discontinued
ANDA 209720Amneal Pharms CoMar 09, 20182—Discontinued
ANDA 210954Amneal Pharms CoJul 02, 20193ABPrescription
ANDA 211975TorrentJul 26, 20213ABPrescription
ANDA 212015TorrentJul 06, 20202ABPrescription
ANDA 212693Zydus LifesciencesMar 07, 20232ABPrescription
ANDA 214549Teva Pharms USA IncFeb 11, 20212ABPrescription
ANDA 215440Zydus PharmsAug 31, 20232—Discontinued
ANDA 215661AlembicAug 24, 20232ABPrescription
ANDA 216066Alkem Labs LtdJul 13, 20222ABPrescription
ANDA 219691Abon Pharms LLCSep 23, 20252ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Erythromycin

View full Erythromycin 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.

Erythromycin: 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 063038 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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