Orange Book product · Brand (NDA)
PENBRITIN-S
AMPICILLIN 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
AMPICILLIN 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EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050072
Product number
006
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.
- —POLYCILLIN-NBrand (NDA)
NDA 050309 · BRISTOL
- 2015AMPICILLIN SODIUMGeneric (ANDA)
ANDA 090583 · SAGENT PHARMS INC
- 2015AMPICILLIN SODIUMGeneric (ANDA)
ANDA 090581 · SAGENT PHARMS INC
- 2015AMPICILLIN SODIUMGeneric (ANDA)
ANDA 202864 · HOSPIRA
- 2015AMPICILLIN SODIUMGeneric (ANDA)
ANDA 202865 · HOSPIRA
- 2014AMPICILLIN SODIUMGeneric (ANDA)
ANDA 201025 · ONESOURCE SPECIALTY
- 2014AMPICILLIN SODIUMGeneric (ANDA)
ANDA 202198 · ONESOURCE SPECIALTY
- 2013AMPICILLIN SODIUMGeneric (ANDA)
ANDA 201404 · ISTITUTO BIO ITA SPA
- 2013AMPICILLIN SODIUMGeneric (ANDA)
ANDA 090884 · ACS DOBFAR SPA
- 2013AMPICILLIN SODIUMGeneric (ANDA)
ANDA 090889 · ACS DOBFAR SPA
- 2010AMPICILLIN SODIUMGeneric (ANDA)
ANDA 065499 · EUGIA PHARMA SPECLTS
- 2010AMPICILLIN SODIUMGeneric (ANDA)
ANDA 065493 · 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.
