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Orange Book drug · Generic (ANDA)

Acyclovir

Acyclovir

ANDA 075677 Apotex
Approved
Sep 28, 2005
Strengths
1
Listed patents
0
Applications
71

What does the FDA Orange Book show for Acyclovir?

Acyclovir contains Acyclovir and appears in 71 FDA Orange Book applications. ANDA 075677 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
71; lead ANDA 075677

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

Lead application holder
Apotex Inc

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
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
001200MGCAPSULEORALPrescriptionAB
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

Apotex Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 075677.

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 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 7 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 075677 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Acyclovir

21 applications
Product rows
21
Active applications
8
Active with AB row
8
Zovirax · NDA 018828

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-075677

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 075677
TE ABRS
Strength
200MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    21 yr 2 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

ACYCLOVIR

Strength

200MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 075677

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 Acyclovir

70 additional filings · 70 generic

The FDA has approved 71 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 Acyclovir, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 203834Hetero Labs Ltd VOct 29, 20132ABPrescription
ANDA 208702Padagis IsraelFeb 04, 20191ABPrescription
ANDA 212252Novitium PharmaJul 10, 20201ABPrescription
ANDA 074556TevaApr 22, 19973—Discontinued
ANDA 074570RoxaneApr 22, 19971—Discontinued
ANDA 074578TevaApr 22, 19971ABPrescription
ANDA 074658Lek PharmApr 22, 19972—Discontinued
ANDA 074674Ivax Sub Teva PharmsApr 22, 19971—Discontinued
ANDA 074727Aurobindo Pharma USAApr 22, 19971—Discontinued
ANDA 074738Actavis Mid AtlanticApr 28, 19971ABPrescription
ANDA 074750Lek PharmApr 22, 19971—Discontinued
ANDA 074828TevaApr 22, 19971—Discontinued
ANDA 074833Strides Pharma IntlApr 22, 19971—Discontinued
ANDA 074834Chartwell MoleculesApr 24, 19972—Discontinued
ANDA 074836Ivax Sub Teva PharmsApr 22, 19972—Discontinued
ANDA 074870Actavis ElizabethJun 05, 19972—Discontinued
ANDA 074872Chartwell MoleculesApr 22, 19971—Discontinued
ANDA 074889HeritageOct 31, 19971ABPrescription
ANDA 074891HeritageOct 31, 19972ABPrescription
ANDA 074906Actavis ElizabethAug 26, 19971—Discontinued
ANDA 074914Teva PharmsNov 26, 19971—Discontinued
ANDA 074946Strides Pharma IntlNov 19, 19972—Discontinued
ANDA 074975RanbaxySep 30, 19981—Discontinued
ANDA 074976MylanApr 13, 19982—Discontinued
ANDA 074977MylanApr 13, 19981—Discontinued
ANDA 074980Sun Pharm Inds LtdSep 30, 19982—Discontinued
ANDA 075021Teva PharmsMar 18, 19982—Discontinued
ANDA 075090Regcon HoldingsJan 26, 19991ABPrescription
ANDA 075101Watson LabsApr 15, 19981—Discontinued
ANDA 075114AbbvieJul 26, 19991—Discontinued
ANDA 075211Aurobindo Pharma USASep 28, 19982ABPrescription
ANDA 075382CarlsbadApr 30, 19992ABPrescription
ANDA 077026HikmaJun 07, 20051—Discontinued
ANDA 077309ApotexSep 29, 20052ABPrescription
ANDA 201445Cadila Pharms LtdMar 06, 20141ABPrescription
ANDA 201501XiromedJan 29, 20201ABPrescription
ANDA 202168Cadila Pharms LtdNov 15, 20132ABPrescription
ANDA 202459PharmobedientApr 03, 20131ABPrescription
ANDA 204313CadilaMar 25, 20161ABPrescription
ANDA 204314Zydus PharmsAug 19, 20142ABPrescription
ANDA 204605Amneal PharmsJun 18, 20141ABPrescription
ANDA 205469Sun Pharma CanadaDec 21, 20161ABPrescription
ANDA 205470Sun Pharma CanadaJun 12, 20241ABPrescription
ANDA 205510Glenmark SpecltJul 31, 20171ABPrescription
ANDA 205591Cosette Pharms NcNov 13, 20171—Discontinued
ANDA 205659Padagis IsraelFeb 20, 20191—Discontinued
ANDA 205974Zydus LifesciencesMar 15, 20191ABPrescription
ANDA 206261CarlsbadAug 16, 20171ABPrescription
ANDA 206437Chartwell MolecularJul 31, 20171—Discontinued
ANDA 206633Fougera Pharms IncMay 11, 20161ABPrescription
ANDA 206770Zydus LifesciencesFeb 28, 20231BXPrescription
ANDA 208766AmnealNov 09, 20201ABPrescription
ANDA 209000AlembicApr 06, 20181ABPrescription
ANDA 209366Square PharmsOct 07, 20192ABPrescription
ANDA 209971TorrentJan 11, 20191ABPrescription
ANDA 210401YilingMar 07, 20182ABPrescription
ANDA 210774ApotexSep 06, 20191—Discontinued
ANDA 211794CiplaJan 18, 20191—Discontinued
ANDA 212173YilingSep 14, 20201ABPrescription
ANDA 212202Prinston IncNov 15, 20211—Discontinued
ANDA 212361AlembicNov 21, 20231ABPrescription
ANDA 212444Macleods Pharms LtdMay 19, 20211ABPrescription
ANDA 212495Chartwell RxApr 07, 20201ABPrescription
ANDA 212718Chartwell RxApr 23, 20201ABPrescription
ANDA 212981CiplaMay 02, 20251—Discontinued
ANDA 213951Vistapharm LLCJan 11, 20211—Discontinued
ANDA 215669Hetero Labs Ltd IIIJul 01, 20221ABPrescription
ANDA 215724Rubicon ResearchAug 18, 20221ABPrescription
ANDA 216331Aurobindo PharmaMar 31, 20221ABPrescription
ANDA 217393MsnMar 09, 20231ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Acyclovir

View full Acyclovir 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.

Acyclovir: 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 075677 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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