Orange Book product · Brand (NDA)
OXACILLIN SODIUM
OXACILLIN 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
OXACILLIN SODIUM
Strength
EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050195
Product number
005
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.
- 1989BACTOCILL IN PLASTIC CONTAINERBrand (NDA)
NDA 050640 · BAXTER HLTHCARE
- —PROSTAPHLINBrand (NDA)
NDA 050118 · APOTHECON
- —PROSTAPHLINBrand (NDA)
NDA 050194 · APOTHECON
- 2020OXACILLIN SODIUMGeneric (ANDA)
ANDA 206199 · FRESENIUS KABI USA
- 2020OXACILLIN SODIUMGeneric (ANDA)
ANDA 206198 · FRESENIUS KABI USA
- 2017OXACILLIN SODIUMGeneric (ANDA)
ANDA 207148 · WOCKHARDT BIO AG
- 2017OXACILLIN SODIUMGeneric (ANDA)
ANDA 206760 · PIRAMAL CRITICAL
- 2017OXACILLIN SODIUMGeneric (ANDA)
ANDA 206681 · PIRAMAL CRITICAL
- 2017OXACILLIN SODIUMGeneric (ANDA)
ANDA 207147 · WOCKHARDT BIO AG
- 2015OXACILLIN SODIUMGeneric (ANDA)
ANDA 203950 · HOSPIRA
- 2014OXACILLIN SODIUMGeneric (ANDA)
ANDA 091486 · ONESOURCE SPECIALTY
- 2013OXACILLIN SODIUMGeneric (ANDA)
ANDA 201539 · EUGIA PHARMA SPECLTS
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.
