Orange Book product · Brand (NDA)

ALKINDI SPRINKLE

HYDROCORTISONE

Brand (NDA)NDA 213876RX ETON

Sep 29, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 29, 2020
5 yr 10 mo ago
Today
Patent 9717740 expires
Listed method-of-use patent (U-3075) expiration.
Nov 19, 2032
in 6 yr 6 mo
Patent 9675559 expires
Listed method-of-use patent (U-3075) expiration.
Jan 10, 2033
in 6 yr 8 mo
Patent 9649280 expires
Listed drug product patent expiration.
May 12, 2034
in 8 yr

Active ingredient

HYDROCORTISONE

Strength

2MG

Dosage form

GRANULE

Route

ORAL

TE code

Not listed

Application

NDA 213876

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9717740	Nov 19, 2032	in 6 yr 6 mo	U-3075
9675559	Jan 10, 2033	in 6 yr 8 mo	U-3075
9649280	May 12, 2034	in 8 yr	ProductU-3075