Orange Book product · Brand (NDA)
CORTISPORIN
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
Not listed
Application
NDA 050479
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —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
- 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.
