Orange Book product · Generic (ANDA)
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
At a glance
Apr 13, 1998
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 1998
28 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Strength
10,000 UNITS/ML;EQ 1MG BASE/ML
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 064211
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
- 1988POLYTRIMBrand (NDA)
NDA 050567 · ALLERGAN
- 2024TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 211572 · SOMERSET THERAPS LLC
- 1998TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065006 · EPIC PHARMA LLC
- 1997TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 064120 · BAUSCH AND LOMB INC
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.
