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Medicines · US (FDA)

FDA 2009

FDA

Acetaminophen

Approved 18 Nov 2009OralTablet, extended release

The FDA lists this product in 36 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: ACETAMINOPHEN 650MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionNDA204767-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA219215-002 · Prescription
ACETAMINOPHEN 500MG/50ML (10MG/ML) · SolutionANDA219215-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionNDA204957-002 · Prescription
ACETAMINOPHEN 500MG/50ML (10MG/ML) · SolutionNDA204957-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionNDA206968-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA219096-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA202605-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA205746-001 · Prescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA210969-001 · Prescription
ACETAMINOPHEN 120MG · SuppositoryANDA073106-001 · Discontinued
ACETAMINOPHEN 120MG · SuppositoryANDA071010-001 · Discontinued

At a glance

Brand name: Acetaminophen
Route: Oral
Dosage form: Tablet, extended release
Applicant: Sun Pharm Inds LTD
Status: Discontinued
FDA approval: 18 Nov 2009
Application: ANDA090205-001

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA204052-001 · Prescription

ACETAMINOPHEN 325MG · SuppositoryANDA073107-001 · Discontinued

ACETAMINOPHEN 650MG · SuppositoryANDA073108-001 · Discontinued

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA075077-001 · Over the counter

ACETAMINOPHEN 650MG · Tablet, extended releaseThis page

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA215403-001 · Prescription

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA215486-001 · Over the counter

ACETAMINOPHEN 120MG · SuppositoryANDA070607-001 · Over the counter

ACETAMINOPHEN 120MG · SuppositoryNDA018337-003 · Over the counter

ACETAMINOPHEN 650MG · SuppositoryNDA018337-001 · Discontinued

ACETAMINOPHEN 325MG · SuppositoryNDA018337-002 · Over the counter

ACETAMINOPHEN 1GM/VIAL · PowderNDA206610-001 · Discontinued

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA211544-001 · Over the counter

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA214331-001 · Prescription

ACETAMINOPHEN 650MG/65ML (10MG/ML) · SolutionANDA214331-002 · Prescription

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA216467-001 · Discontinued

ACETAMINOPHEN 650MG · SuppositoryANDA070608-001 · Over the counter

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA076200-001 · Over the counter

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA078569-001 · Discontinued

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA207035-001 · Discontinued

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA213255-001 · Prescription

ACETAMINOPHEN 1GM/100ML (10MG/ML) · SolutionANDA216617-001 · Prescription

ACETAMINOPHEN 650MG · SuppositoryANDA071011-001 · Discontinued

ACETAMINOPHEN 650MG · Tablet, extended releaseANDA207229-001 · Over the counter

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA090205.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.