Orange Book product · Brand (NDA)
POLYSPORIN
BACITRACIN ZINC; POLYMYXIN B SULFATE
At a glance
Mar 01, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 1985
41 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BACITRACIN ZINC; POLYMYXIN B SULFATE
Strength
10,000 UNITS/GM;2,000,000 UNITS/GM
Dosage form
AEROSOL
Route
TOPICAL
TE code
Not listed
Application
NDA 050167
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2002BACITRACIN ZINC AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065022 · PADAGIS US
- 1995BACITRACIN ZINC AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 064028 · SCIEGEN PHARMS
- 1995BACITRACIN ZINC AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 064046 · BAUSCH AND LOMB INC
- 1987BACITRACIN ZINC-POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 062849 · NASKA
- 1983OCUMYCINGeneric (ANDA)
ANDA 062430 · PHARMAFAIR
- —POLYSPORINGeneric (ANDA)
ANDA 061229 · MONARCH 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.
