Orange Book product · Generic (ANDA)
OMNIPEN-N
AMPICILLIN SODIUM
At a glance
Dec 16, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 1986
40 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPICILLIN SODIUM
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 062718
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPICILLIN SODIUM
- —PENBRITIN-SBrand (NDA)
NDA 050072 · WYETH AYERST
- —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
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.
