Orange Book drug · Brand (NDA)

Levetiracetam In Sodium Chloride

Levetiracetam

RLDNDA 202543 4 strengths Hq Spclt Pharma

Approved

Nov 09, 2011

Strengths

Listed patents

Applications

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

Levetiracetam In Sodium Chloride contains Levetiracetam and appears in 10 FDA Orange Book applications. NDA 202543 is the lead filing, with 4 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: 10; lead NDA 202543
Lead application holder: Hq Specialty Pharma Corp
Product presentations: 4
Marketing categories: Prescription and Discontinued
Reference roles: RLD / RS
TE codes: AP
Listed patents: 0
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	500MG/100ML (5MG/ML)	INJECTABLEINTRAVENOUS	Prescription	AP	RLDRS
002	1GM/100ML (10MG/ML)	INJECTABLEINTRAVENOUS	Prescription	AP	RLDRS
003	1.5GM/100ML (15MG/ML)	INJECTABLEINTRAVENOUS	Prescription	AP	RLDRS
004	250MG/50ML (5MG/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

Hq Specialty Pharma Corp

The Orange Book identifies this organization as the applicant responsible for NDA 202543.

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

Status varies by presentation: 3 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

TE code AP across rated presentations

An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 1 presentation in the application has no posted TE code.

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

96 other ANDAs and 6 other NDAs found

56 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 202543 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

Levetiracetam

28 applications

Product rows: 49
Active applications: 22
Active with AB row: 0

Keppra · NDA 021872 Levetiracetam · ANDA 215465 Levetiracetam · ANDA 215980 Levetiracetam · ANDA 209474 Levetiracetam · ANDA 211954

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-202543

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

4 approved presentations · NDA 202543

TE APRLDRS

Strength: 500MG/100ML (5MG/ML)
Dosage form: INJECTABLE
Route: INTRAVENOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Nov 09, 2011
14 yr 11 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

LEVETIRACETAM

Strength

500MG/100ML (5MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 202543

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

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 Levetiracetam In Sodium Chloride

9 additional filings · 9 generic

The FDA has approved 10 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 Levetiracetam In Sodium Chloride, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 206880	Gland	Oct 25, 2017	3	AP	Prescription
ANDA 207160	Eugia Pharma	Jan 04, 2017	3	AP	Prescription
ANDA 208619	Fresenius Kabi USA	Jan 31, 2023	3	AP	Prescription
ANDA 209705	B Braun Medical	Feb 27, 2024	3	AP	Prescription
ANDA 211356	Hikma	Feb 12, 2024	3	AP	Prescription
ANDA 213532	Nexus	Jul 06, 2020	3	AP	Prescription
ANDA 217059	Baxter Hlthcare Corp	Oct 02, 2023	3	AP	Prescription
ANDA 218364	Mylan Labs Ltd	May 08, 2026	3	AP	Prescription
ANDA 219562	Caplin	Jan 16, 2025	3	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 Levetiracetam 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.