Orange Book product · Generic (ANDA)
POLYSPORIN
BACITRACIN ZINC; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
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; POLYMYXIN B SULFATE
Strength
500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**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
Not listed
Application
ANDA 061229
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; POLYMYXIN B SULFATE
- 1985POLYSPORINBrand (NDA)
NDA 050167 · GLAXOSMITHKLINE
- 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
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.
