Orange Book product · Brand (NDA)

HEMANGEOL

PROPRANOLOL HYDROCHLORIDE

Brand (NDA)NDA 205410RX ETON

Mar 14, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 14, 2014
12 yr 5 mo ago
Today
Patent 8338489 expires
Listed method-of-use patent (U-1496) expiration.
Oct 16, 2028
in 2 yr 4 mo
Patent 8987262 expires
Listed method-of-use patent (U-1988) expiration.
Oct 16, 2028
in 2 yr 4 mo

Active ingredient

PROPRANOLOL HYDROCHLORIDE

Strength

4.28MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 205410

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8338489	Oct 16, 2028	in 2 yr 4 mo	U-1496
8987262	Oct 16, 2028	in 2 yr 4 mo	U-1988