You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 211302


✉ Email this page to a colleague

« Back to Dashboard


NDA 211302 describes CYSTADROPS, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTADROPS profile page.

The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
Summary for 211302
Tradename:CYSTADROPS
Applicant:Recordati Rare
Ingredient:cysteamine hydrochloride
Patents:0
Pharmacology for NDA: 211302
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 211302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTADROPS cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 211302 NDA RECORDATI RARE DISEASES, INC. 55292-410 55292-410-05 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.37% BASE
Approval Date:Aug 19, 2020TE:RLD:Yes

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. 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.