Orange Book drug · Brand (NDA)

Sulfamethoxazole And Trimethoprim Double Strength

Sulfamethoxazole; Trimethoprim

DiscontinuedNDA 018598 Fosun Pharma

Approved

May 19, 1982

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Sulfamethoxazole And Trimethoprim Double Strength?

Sulfamethoxazole And Trimethoprim Double Strength contains Sulfamethoxazole; Trimethoprim and appears in 6 FDA Orange Book applications. NDA 018598 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: 6; lead NDA 018598
Lead application holder: Fosun Pharma USA Inc
Product presentations: 1
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
004	800MG;160MG	TABLETORAL	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

Fosun Pharma USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 018598.

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A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.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

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

48 other ANDAs and 11 other NDAs found

13 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 018598 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Sulfamethoxazole; Trimethoprim

38 applications

Product rows: 50
Active applications: 7
Active with AB row: 7

Sulfamethoxazole And Trimethoprim · NDA 018946 Sulfamethoxazole And Trimethoprim · NDA 018852 Bactrim · NDA 017377 Septra · NDA 017376 Sulfamethoxazole And Trimethoprim · NDA 018242 Sulfamethoxazole And Trimethoprim · ANDA 090828

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-018598

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 018598

Discontinued

Strength: 800MG;160MG
Dosage form: TABLET
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
May 19, 1982
44 yr 10 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Strength

800MG;160MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 018598

Product number

004

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 Sulfamethoxazole And Trimethoprim Double Strength

5 additional filings · 4 generic

The FDA has approved 6 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 Sulfamethoxazole And Trimethoprim Double Strength, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 018854	Watson Labs	May 09, 1983	1	—	Discontinued
ANDA 070007	Mutual Pharm	Nov 14, 1984	1	—	Discontinued
ANDA 070037	Heritage Pharma Avet	Jun 02, 1987	1	—	Discontinued
ANDA 072417	Martec USA LLC	Dec 07, 1988	1	—	Discontinued
ANDA 072769	Roxane	Aug 30, 1991	1	—	Discontinued

Active-ingredient family

Brand + generics

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Sulfamethoxazole; Trimethoprim 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.