Orange Book product · Brand (NDA)
POLYTRIM
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
At a glance
Oct 20, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 1988
38 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Strength
10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050567
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 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.
