Orange Book product · Brand (NDA)
NALLPEN IN PLASTIC CONTAINER
NAFCILLIN SODIUM
At a glance
Oct 31, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 1989
37 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
NAFCILLIN SODIUM
Strength
EQ 2GM BASE/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050655
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —UNIPENBrand (NDA)
NDA 050111 · WYETH AYERST
- —UNIPENBrand (NDA)
NDA 050199 · WYETH AYERST
- —UNIPENBrand (NDA)
NDA 050320 · 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.
