Orange Book drug · Generic (ANDA)

Butalbital And Acetaminophen

Acetaminophen; Butalbital

DiscontinuedRLDANDA 087550 Watson Labs

Approved

Oct 19, 1984

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Butalbital And Acetaminophen?

Butalbital And Acetaminophen contains Acetaminophen; Butalbital and appears in 13 FDA Orange Book applications. ANDA 087550 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: 13; lead ANDA 087550
Lead application holder: Watson Laboratories Inc
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
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	325MG;50MG	TABLETORAL	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

Watson Laboratories Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 087550.

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A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.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

10 other ANDAs and 0 other NDAs found

2 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 087550 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

Acetaminophen; Butalbital

15 applications

Product rows: 18
Active applications: 8
Active with AB row: 0

Allzital · ANDA 203484 Butapap · ANDA 089987 Butapap · ANDA 089988

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-087550

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 087550

RLDDiscontinued

Strength: 325MG;50MG
Dosage form: TABLET
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Oct 19, 1984
42 yr 5 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; BUTALBITAL

Strength

325MG;50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 087550

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

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 Butalbital And Acetaminophen

12 additional filings · 12 generic

The FDA has approved 13 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 Butalbital And Acetaminophen, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 090956	Lgm Pharma	Aug 23, 2011	1	AA	Prescription
ANDA 207313	DR Reddys Labs Sa	Dec 27, 2017	1	AA	Prescription
ANDA 089568	Halsey	Oct 05, 1988	1	—	Discontinued
ANDA 203484	Pharmobedient	Dec 04, 2015	1	AA	Prescription
ANDA 205120	Alvogen	Oct 30, 2015	1	—	Discontinued
ANDA 207386	Anda Repository	Nov 15, 2016	1	AA	Prescription
ANDA 207635	Alvogen	Jun 05, 2017	1	—	Discontinued
ANDA 213115	Granules	Nov 22, 2019	1	AA	Prescription
ANDA 214088	Senores Pharms	Apr 07, 2022	3	AA	Prescription
ANDA 214291	Quagen	Jan 18, 2024	1	AA	Prescription
ANDA 214305	Quagen	Feb 01, 2024	1	AA	Prescription
ANDA 214955	Ne Rx Pharma	Aug 16, 2022	1	AA	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Acetaminophen; Butalbital

View full Acetaminophen; Butalbital 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.