Orange Book product · Generic (ANDA)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Oct 29, 2025
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
AT
Application
ANDA 217803
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- —CORTISPORINBrand (NDA)
NDA 050479 · MONARCH PHARMS
- —CORTISPORINBrand (NDA)
NDA 050169 · MONARCH PHARMS
- —CASPORYN HCBrand (NDA)
NDA 060613 · CASPER PHARMA LLC
- 2025NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 217735 · AMNEAL
- 2006NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 065219 · SCIEGEN PHARMS
- 2005NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 065216 · SAPTALIS PHARMS
- 1996OTICAIRGeneric (ANDA)
ANDA 064065 · BAUSCH AND LOMB INC
- 1995NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 064053 · BAUSCH AND LOMB INC
- 1988NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 062874 · SANDOZ
- 1987PEDIOTICGeneric (ANDA)
ANDA 062822 · MONARCH PHARMS
- 1985NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEGeneric (ANDA)
ANDA 062488 · SANDOZ
- 1985NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONEGeneric (ANDA)
ANDA 062623 · 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.
