Orange Book drug · Generic (ANDA)

Ampicillin And Sulbactam

Ampicillin Sodium; Sulbactam Sodium

DiscontinuedANDA 065074 2 strengths Hikma

Approved

Mar 19, 2002

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Ampicillin And Sulbactam?

Ampicillin And Sulbactam contains Ampicillin Sodium; Sulbactam Sodium and appears in 23 FDA Orange Book applications. ANDA 065074 is the lead filing, with 2 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: 23; lead ANDA 065074
Lead application holder: Hikma Pharmaceuticals USA Inc
Product presentations: 2
Marketing categories: Discontinued
Reference roles: None posted
TE codes: None posted
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	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLEINJECTION	Discontinued	None posted	None posted
002	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLEINJECTION	Discontinued	None posted	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

Hikma Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 065074.

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

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A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.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

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 1 other NDA 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 065074 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 · Injection

Ampicillin Sodium; Sulbactam Sodium

25 applications

Product rows: 43
Active applications: 15
Active with AB row: 0

Unasyn · NDA 050608

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-065074

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

2 approved presentations · ANDA 065074

Discontinued

Strength: EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Dosage form: INJECTABLE
Route: INJECTION
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Mar 19, 2002
24 yr 9 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 065074

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

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 Ampicillin And Sulbactam

22 additional filings · 22 generic

The FDA has approved 23 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 Ampicillin And Sulbactam, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 065076	Hikma	Mar 19, 2002	1	AP	Prescription
ANDA 065176	Hq Speclt Pharma	Nov 30, 2005	2	AP	Prescription
ANDA 065188	Hq Speclt Pharma	Nov 25, 2005	1	AP	Prescription
ANDA 065222	Istituto Bio Ita Spa	Nov 29, 2005	2	AP	Prescription
ANDA 065240	Sandoz	Jul 25, 2006	1	AP	Prescription
ANDA 065241	Sandoz	Jul 25, 2006	2	AP	Prescription
ANDA 065310	Sandoz	Jul 25, 2006	2	—	Discontinued
ANDA 065314	Istituto Bio Ita Spa	Nov 27, 2006	1	AP	Prescription
ANDA 065316	Eurofarma	Jun 29, 2007	2	—	Discontinued
ANDA 065403	Acs Dobfar	Dec 23, 2009	1	AP	Prescription
ANDA 065406	Acs Dobfar	Dec 22, 2009	2	AP	Prescription
ANDA 090339	Eugia Pharma Speclts	Sep 20, 2010	1	AP	Prescription
ANDA 090340	Eugia Pharma Speclts	Sep 20, 2010	2	—	Discontinued
ANDA 090349	Eugia Pharma Speclts	Sep 20, 2010	2	AP	Prescription
ANDA 090375	Hospira Inc	Dec 21, 2011	2	—	Discontinued
ANDA 090578	Astral	Jan 11, 2016	1	—	Discontinued
ANDA 090579	Astral	Jan 08, 2016	2	—	Discontinued
ANDA 090646	Hospira Inc	Dec 21, 2011	1	—	Discontinued
ANDA 090653	Hospira Inc	Dec 21, 2011	2	—	Discontinued
ANDA 201024	Onesource Specialty	Apr 07, 2014	2	AP	Prescription
ANDA 201406	Antibiotice	Dec 07, 2015	2	AP	Prescription
ANDA 202197	Onesource Specialty	Apr 07, 2014	1	AP	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Ampicillin Sodium; Sulbactam Sodium

View full Ampicillin Sodium; Sulbactam Sodium 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.