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Orange Book drug · Generic (ANDA)

Doxycycline

Doxycycline

ANDA 065053 3 strengths Sun Pharm Inds Ltd
Approved
Nov 22, 2000
Strengths
3
Listed patents
0
Applications
34

What does the FDA Orange Book show for Doxycycline?

Doxycycline contains Doxycycline and appears in 34 FDA Orange Book applications. ANDA 065053 is the lead filing, with 3 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
34; lead ANDA 065053

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

Lead application holder
Sun Pharmaceutical Industries Ltd

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

Product presentations
3

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
001EQ 50MG BASECAPSULEORALPrescriptionAB
None posted
002EQ 100MG BASECAPSULEORALPrescriptionAB
RS
003EQ 75MG BASECAPSULEORALPrescriptionAB
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

Sun Pharmaceutical Industries Ltd

The Orange Book identifies this organization as the applicant responsible for ANDA 065053.

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

3 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

1 other ANDA 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 065053 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-065053

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

3 approved presentations · ANDA 065053
TE AB
Strength
EQ 50MG BASE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    26 yr 1 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

DOXYCYCLINE

Strength

EQ 50MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 065053

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 Doxycycline

33 additional filings · 33 generic

The FDA has approved 34 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 Doxycycline, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 065055Strides Pharma IntlJul 15, 20054ABPrescription
ANDA 091605HeritageDec 20, 20114ABPrescription
ANDA 201678Lupin LtdMar 18, 20131ABPrescription
ANDA 207757Zydus PharmsSep 28, 20172APPrescription
ANDA 062450HikmaOct 27, 19832—Discontinued
ANDA 062569HikmaMar 09, 19882—Discontinued
ANDA 065032Sandoz IncJun 30, 20002—Discontinued
ANDA 065041Watson LabsApr 28, 20002—Discontinued
ANDA 065070Strides Pharma IntlDec 15, 20004ABPrescription
ANDA 065285Lannett Co IncDec 08, 20054ABPrescription
ANDA 065353Sandoz IncNov 27, 20063—Discontinued
ANDA 065356Sun Pharm Inds LtdMay 31, 20064ABPrescription
ANDA 065377Chartwell RxNov 07, 20063—Discontinued
ANDA 065427Chartwell RxJun 07, 20071—Discontinued
ANDA 065454ChartwellJul 16, 20081ABPrescription
ANDA 065471Sun Pharm IndustriesApr 17, 20093—Discontinued
ANDA 091406Mylan Labs LtdAug 21, 20121APPrescription
ANDA 200065Impax Labs IncFeb 17, 20111—Discontinued
ANDA 202778Strides PharmaJun 08, 20121—Discontinued
ANDA 204234LupinMar 05, 20143ABPrescription
ANDA 204446CosetteMay 28, 20153—Discontinued
ANDA 205115Zydus PharmsFeb 18, 20163ABPrescription
ANDA 208942RisingJan 21, 20213—Discontinued
ANDA 209165AlembicJul 28, 20172ABPrescription
ANDA 209396DR Reddys Labs SaSep 29, 20173ABPrescription
ANDA 209582Zydus PharmsSep 28, 20174ABPrescription
ANDA 210381Macleods Pharms LtdMar 27, 20251ABPrescription
ANDA 216631LupinApr 08, 20241ABPrescription
ANDA 217098Prinston IncJan 27, 20251ABPrescription
ANDA 217170ApotexJul 11, 20241ABPrescription
ANDA 217674AlembicJun 27, 20241ABPrescription
ANDA 218034DR ReddysApr 08, 20241ABPrescription
ANDA 219978Aiping Pharm IncOct 01, 20251ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Doxycycline

View full Doxycycline 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.

Doxycycline: 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 065053 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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