Orange Book product · Brand (NDA)
LUMI-SPORYN
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
AT
Application
NDA 050417
Product number
001
Marketing status
RX
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.
- 2004NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCGeneric (ANDA)
ANDA 065088 · SCIEGEN PHARMS
- 1995NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCGeneric (ANDA)
ANDA 064064 · BAUSCH AND LOMB INC
- 1987BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 062833 · NASKA
- 1982BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 062386 · PHARMAFAIR
- —BACITRACIN-NEOMYCIN-POLYMYXINGeneric (ANDA)
ANDA 062167 · PHARMADERM
- —NEO-POLYCINGeneric (ANDA)
ANDA 060647 · DOW PHARM
- —NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCGeneric (ANDA)
ANDA 060764 · PADAGIS US
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.
