Orange Book product · Brand (NDA)
ERYCETTE
ERYTHROMYCIN
At a glance
Feb 15, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 15, 1985
41 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ERYTHROMYCIN
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SWAB
Route
TOPICAL
TE code
Not listed
Application
NDA 050594
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.
- 1987ERYGELBrand (NDA)
NDA 050617 · MYLAN
- 1986ERYTHROMYCINBrand (NDA)
NDA 050610 · PADDOCK LLC
- 1985ERYC SPRINKLESBrand (NDA)
NDA 050593 · HOSPIRA
- 1985AKNE-MYCINBrand (NDA)
NDA 050584 · BAUSCH
- —ERYCBrand (NDA)
NDA 050536 · DR REDDYS LABS SA
- —ILOTYCINBrand (NDA)
NDA 050368 · DISTA
- —ERYTHROMYCINBrand (NDA)
NDA 050532 · LILLY
- —STATICINBrand (NDA)
NDA 050526 · WESTWOOD SQUIBB
- 2017ERYTHROMYCINGeneric (ANDA)
ANDA 208100 · ENCUBE
- 2017ERYTHROMYCINGeneric (ANDA)
ANDA 208154 · ENCUBE
- 2010ERYTHROMYCINGeneric (ANDA)
ANDA 090215 · EPIC PHARMA LLC
- 2006ERYTHROMYCINGeneric (ANDA)
ANDA 065320 · FOUGERA PHARMS
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.
