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Generated: November 15, 2018

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Details for New Drug Application (NDA): 210565

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NDA 210565 describes INVELTYS, which is a drug marketed by Kala Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the INVELTYS profile page.

The generic ingredient in INVELTYS is loteprednol etabonate. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 210565
Tradename:INVELTYS
Applicant:Kala Pharms Inc
Ingredient:loteprednol etabonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210565
Medical Subject Heading (MeSH) Categories for 210565
Suppliers and Packaging for NDA: 210565
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565 NDA Kala Pharmaceuticals, Inc. 71571-121 71571-121-28 1 BOTTLE, DROPPER in 1 CARTON (71571-121-28) > 2.8 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Aug 22, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 22, 2021
Regulatory Exclusivity Use:NEW PRODUCT

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