Orange Book product · Brand (NDA)
UNIPEN
NAFCILLIN SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NAFCILLIN SODIUM
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050320
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.
- 1989NALLPEN IN PLASTIC CONTAINERBrand (NDA)
NDA 050655 · BAXTER HLTHCARE
- —UNIPENBrand (NDA)
NDA 050111 · WYETH AYERST
- —UNIPENBrand (NDA)
NDA 050199 · WYETH AYERST
- —UNIPENBrand (NDA)
NDA 050462 · WYETH AYERST
- 2020NAFCILLIN SODIUMGeneric (ANDA)
ANDA 206761 · FRESENIUS
- 2019NAFCILLIN SODIUMGeneric (ANDA)
ANDA 206682 · FRESENIUS
- 2014NAFCILLIN SODIUMGeneric (ANDA)
ANDA 200002 · ONESOURCE SPECIALTY
- 2012NAFCILLIN SODIUMGeneric (ANDA)
ANDA 091613 · EUGIA PHARMA SPECLTS
- 2012NAFCILLIN SODIUMGeneric (ANDA)
ANDA 091614 · EUGIA PHARMA SPECLTS
- 2012NAFCILLIN SODIUMGeneric (ANDA)
ANDA 090582 · SAGENT PHARMS
- 2012NAFCILLIN SODIUMGeneric (ANDA)
ANDA 090580 · SAGENT PHARMS
- 2011NAFCILLIN SODIUMGeneric (ANDA)
ANDA 090560 · ANTIBIOTICE
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.
