Orange Book product · Generic (ANDA)
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Jul 25, 1994
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 1994
32 yr 4 mo ago
Today
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
ANDA 064063
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- —MAXITROLBrand (NDA)
NDA 050065 · SANDOZ
- —MAXITROLBrand (NDA)
NDA 050023 · HARROW EYE
- 1995DEXASPORINGeneric (ANDA)
ANDA 064135 · 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.
