FDA Orange Book · active-ingredient family
Hydrocortisone; neomycin sulfate; polymyxin b sulfate
Hydrocortisone; neomycin sulfate; polymyxin b sulfate: 3 brands, 18 generics; first approved Sep 29, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
18
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- CORTISPORINRLDMONARCH PHARMSNDA 050479—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Discontinued — - CASPORYN HCRLDCASPER PHARMA LLCNDA 060613—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Rx AT - MONARCH PHARMSNDA 050169—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OPHTHALMIC Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- ORBICULAR PHARM TECHANDA 2209382026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Rx AT - AMNEALANDA 2178032025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Rx AT - AMNEALANDA 2177352025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Rx AT - SCIEGEN PHARMSANDA 0652192006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Rx AT - SAPTALIS PHARMSANDA 0652162005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Discontinued — - OTICAIRRSBAUSCH AND LOMB INCANDA 0640651996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Rx AT - BAUSCH AND LOMB INCANDA 0640531995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Rx AT - SANDOZANDA 0628741988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OPHTHALMIC Rx — - MONARCH PHARMSANDA 0628221987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Discontinued — - SANDOZANDA 0624881985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Rx AT - PHARMAFAIRANDA 0626231985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OPHTHALMIC Discontinued — - PHARMAFAIRANDA 0626171985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Discontinued — - WATSON LABSANDA 0625211985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Discontinued — - SANDOZANDA 0624231983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Rx AT - PHARMAFAIRANDA 0623991982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Discontinued — - PHARMAFAIRANDA 0623941982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Discontinued — - WATSON LABSANDA 060730—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS OTIC Discontinued — - SCHERINGANDA 061816—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS OTIC Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
26 d ago
Approvals span 1982–2026 across 21 FDA applications.
Brand (NDA) 314%
Generic (ANDA) 1886%
Hydrocortisone; neomycin sulfate; polymyxin b sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
