Orange Book product · Generic (ANDA)
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
At a glance
Feb 14, 1997
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 14, 1997
29 yr 9 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 064120
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 1998TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 064211 · SANDOZ
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.
