Orange Book product · Brand (NDA)
MAXITROL
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
AT
Application
NDA 050065
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —MAXITROLBrand (NDA)
NDA 050023 · HARROW EYE
- 1995DEXASPORINGeneric (ANDA)
ANDA 064135 · BAUSCH AND LOMB INC
- 1994NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEGeneric (ANDA)
ANDA 064063 · BAUSCH AND LOMB INC
- 1989NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEGeneric (ANDA)
ANDA 062938 · PADAGIS US
- 1986NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEGeneric (ANDA)
ANDA 062721 · ALCON PHARMS LTD
- 1985DEXACIDINGeneric (ANDA)
ANDA 062566 · NOVARTIS
- 1984DEXACIDINGeneric (ANDA)
ANDA 062544 · NOVARTIS
- 1984MAXITROLGeneric (ANDA)
ANDA 062341 · SANDOZ
- 1983DEXASPORINGeneric (ANDA)
ANDA 062428 · PHARMAFAIR
- 1983DEXASPORINGeneric (ANDA)
ANDA 062411 · 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.
