Orange Book product · Brand (NDA)
PATHOCIL
DICLOXACILLIN SODIUM
At a glance
Mar 28, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 1983
43 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOXACILLIN SODIUM
Strength
EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 050011
Product number
003
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.
- —DYNAPENBrand (NDA)
NDA 050337 · APOTHECON
- —PATHOCILBrand (NDA)
NDA 050092 · WYETH AYERST
- 2022DICLOXACILLIN SODIUMGeneric (ANDA)
ANDA 216845 · AUROBINDO PHARMA
- 1982DICLOXACILLIN SODIUMGeneric (ANDA)
ANDA 062286 · TEVA
- —DICLOXACILLIN SODIUMGeneric (ANDA)
ANDA 061454 · CHARTWELL RX
- —DYCILLGeneric (ANDA)
ANDA 060254 · GLAXOSMITHKLINE
- —DYCILLGeneric (ANDA)
ANDA 062238 · GLAXOSMITHKLINE
- —DICLOXACILLIN SODIUMGeneric (ANDA)
ANDA 061455 · APOTHECON
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.
