Orange Book drug · Brand (NDA)

Argatroban In Sodium Chloride

Argatroban

DiscontinuedRLDNDA 022434 Cipla

Approved

Jun 29, 2011

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Argatroban In Sodium Chloride?

Argatroban In Sodium Chloride contains Argatroban and appears in 5 FDA Orange Book applications. NDA 022434 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: 5; lead NDA 022434
Lead application holder: Cipla Ltd
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 2
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

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.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	50MG/50ML (1MG/ML)	INJECTABLEINTRAVENOUS	Discontinued	None posted	RLD

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

Cipla Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 022434.

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 on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

2 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Sep 26, 2027. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

6 other ANDAs and 5 other NDAs found

6 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

NDA 022434 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Injectable · Intravenous

Argatroban

4 applications

Product rows: 4
Active applications: 2
Active with AB row: 0

Argatroban In 0.9% Sodium Chloride · NDA 206769

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-022434

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

NDA 022434

RLDDiscontinued

Strength: 50MG/50ML (1MG/ML)
Dosage form: INJECTABLE
Route: INTRAVENOUS
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Jun 29, 2011
15 yr 4 mo ago
Today
Patent 7589106 expires
Listed drug product patent expiration.
Sep 26, 2027
in 1 yr 2 mo
Patent 7687516 expires
Listed drug product patent expiration.
Sep 26, 2027
in 1 yr 2 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ARGATROBAN

Strength

50MG/50ML (1MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022434

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7589106	Sep 26, 2027	in 1 yr 2 mo	ProductU-1163
7687516	Sep 26, 2027	in 1 yr 2 mo	ProductU-1164

Other FDA applications for Argatroban In Sodium Chloride

4 additional filings · 1 generic

The FDA has approved 5 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 Argatroban In Sodium Chloride, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 022485	Plano Pharms	May 09, 2011	1	AP	Prescription
NDA 212035	Accord Hlthcare	Jun 07, 2021	1	—	Prescription
NDA 209552	Eugia Pharma Speclts	Nov 27, 2018	1	—	Prescription
ANDA 205570	Gland	May 22, 2017	1	AP	Prescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Argatroban 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.