Orange Book product · Brand (NDA)
CORTISPORIN
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050416
Product number
002
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.
- 1984CORTISPORINBrand (NDA)
NDA 050168 · MONARCH PHARMS
- 2012NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEGeneric (ANDA)
ANDA 065213 · SCIEGEN PHARMS
- 1995NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEGeneric (ANDA)
ANDA 064068 · BAUSCH AND LOMB INC
- 1985NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONEGeneric (ANDA)
ANDA 062381 · PHARMAFAIR
- 1982ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONEGeneric (ANDA)
ANDA 062389 · PHARMAFAIR
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.
