Orange Book product · Generic (ANDA)
AMPICILLIN AND SULBACTAM
AMPICILLIN SODIUM; SULBACTAM SODIUM
At a glance
Jan 11, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 2016
10 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPICILLIN SODIUM; SULBACTAM SODIUM
Strength
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 090578
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPICILLIN SODIUM; SULBACTAM SODIUM
- 1986UNASYNBrand (NDA)
NDA 050608 · PFIZER
- 2016AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090579 · ASTRAL
- 2015AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 201406 · ANTIBIOTICE
- 2014AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 201024 · ONESOURCE SPECIALTY
- 2014AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 202197 · ONESOURCE SPECIALTY
- 2011AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090375 · HOSPIRA INC
- 2011AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090653 · HOSPIRA INC
- 2011AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090646 · HOSPIRA INC
- 2010AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090340 · EUGIA PHARMA SPECLTS
- 2010AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090349 · EUGIA PHARMA SPECLTS
- 2010AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 090339 · EUGIA PHARMA SPECLTS
- 2009AMPICILLIN AND SULBACTAMGeneric (ANDA)
ANDA 065403 · ACS DOBFAR
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.
