Orange Book product · Generic (ANDA)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Dec 29, 1995
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1995
30 yr 11 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 064053
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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 217803 · AMNEAL
- 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
- 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.
