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Medicines · US (FDA)
NSAIDs

FDA 2023

Other dermatologicals

Diclofenac Sodium and Misoprostol

Approved 12 Jun 2023OralTablet, delayed release

The FDA lists this product in 14 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: DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG

Strengths and forms

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

DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA206771-002 · Discontinued
DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseThis page
DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA200540-002 · Discontinued
DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA200540-001 · Discontinued
DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA201089-002 · Prescription
DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA201089-001 · Prescription
DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA203995-002 · Prescription
DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed release

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ANDA203995-001 · Prescription

DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA200158-002 · Discontinued

DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA200158-001 · Discontinued

DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA204355-002 · Prescription

DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA204355-001 · Prescription

DICLOFENAC SODIUM 75MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA205143-002 · Prescription

DICLOFENAC SODIUM 50MG; MISOPROSTOL 0.2MG · Tablet, delayed releaseANDA205143-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA206771.

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.

At a glance

Brand name: Diclofenac Sodium and Misoprostol
Active substance: diclofenac sodium
Drug class: Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
Group: NSAIDs
Route: Oral
Dosage form: Tablet, delayed release
Applicant: Zydus Pharms
Status: Discontinued
FDA approval: 12 Jun 2023
Application: ANDA206771-001
RxCUI: 203214

Guidelines

Guidelines in rheumatology364 guidelines in the library

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Qamzovameloxicam · Solution

FDA 2023Coxantooxaprozin · Capsule

FDA 2023Acetaminophen and Ibuprofenacetaminophen · Tablet

FDA 2021Ibuprofen and Famotidinefamotidine · Tablet

FDA 2021Zynrelef Kitbupivacaine · Solution, extended release

FDA 2020MeloxicamCapsule

FDA 2020Advil Dual Action with Acetaminophenacetaminophen · Tablet

FDA 2018Licartdiclofenac epolamine · System

FDA 2018Naproxen Sodium and Diphenhydramine Hydrochloridediphenhydramine hydrochloride · Tablet

FDA 2018Naproxen and Esomeprazole Magnesiumesomeprazole magnesium · Tablet, delayed release

FDA 2018Consensiamlodipine besylate · Tablet

FDA 2018Sumatriptan and Naproxen Sodiumnaproxen sodium · Tablet

FDA 2017Ibuprofen and Pseudoephedrine Hydrochlorideibuprofen · Capsule

FDA 2016DiclofenacCapsule

FDA 2016Diclofenac PotassiumFor solution

FDA 2016Ibuprofen LysineInjectable