Orange Book product · Generic (ANDA)
NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Aug 31, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 1982
44 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 062383
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- 2005NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINGeneric (ANDA)
ANDA 065187 · SCIEGEN PHARMS
- 1996NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINGeneric (ANDA)
ANDA 064047 · BAUSCH AND LOMB INC
- 1988NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINGeneric (ANDA)
ANDA 062818 · IPHARM
- 1987NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINGeneric (ANDA)
ANDA 062788 · WATSON LABS
- —NEO-POLYCINGeneric (ANDA)
ANDA 060427 · DOW PHARM
- —NEOSPORINGeneric (ANDA)
ANDA 060582 · MONARCH PHARMS
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.
