Orange Book product · Brand (NDA)
ESTRASORB
ESTRADIOL HEMIHYDRATE
Brand (NDA)NDA 021371DISCN EXELTIS USA INC
At a glance
Oct 09, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 2003
23 yr ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL HEMIHYDRATE
Strength
0.25%
Dosage form
EMULSION
Route
TOPICAL
TE code
Not listed
Application
NDA 021371
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
