Last Updated: September 25, 2026

Details for New Drug Application (NDA): 219441

✉ Email this page to a colleague

« Back to Dashboard

NDA 219441 describes DIFLUPREDNATE, which is a drug marketed by Alembic, Amneal, Caplin, Cipla, Dr Reddys, Epic Pharma Llc, Mylan Labs Ltd, and Upsher Smith Labs, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the DIFLUPREDNATE profile page.

The generic ingredient in DIFLUPREDNATE is difluprednate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the difluprednate profile page.

Summary for 219441

Tradename:	DIFLUPREDNATE
Applicant:	Caplin
Ingredient:	difluprednate
Patents:	0

Suppliers and Packaging for NDA: 219441

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	219441	ANDA	Caplin Steriles Limited	65145-161	65145-161-01	1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	219441	ANDA	Leading Pharma, LLC	69315-329	69315-329-05	1 BOTTLE in 1 CARTON (69315-329-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Dec 13, 2024	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.