Orange Book product · Generic (ANDA)
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Sep 09, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 09, 1982
44 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 062386
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- —LUMI-SPORYNBrand (NDA)
NDA 050417 · CASPER PHARMA LLC
- 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
- —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.
