Orange Book product · Generic (ANDA)
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Oct 30, 1995
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 1995
31 yr 1 mo ago
Today
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
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 064068
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- 1984CORTISPORINBrand (NDA)
NDA 050168 · MONARCH PHARMS
- —CORTISPORINBrand (NDA)
NDA 050416 · CASPER PHARMA LLC
- 2012NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEGeneric (ANDA)
ANDA 065213 · SCIEGEN PHARMS
- 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.
