Orange Book product · Brand (NDA)
PENBRITIN
AMPICILLIN/AMPICILLIN TRIHYDRATE
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/AMPICILLIN TRIHYDRATE
Strength
EQ 100MG BASE/ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050019
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —POLYCILLINBrand (NDA)
NDA 050310 · BRISTOL
- —PRINCIPEN '250'Brand (NDA)
NDA 050056 · APOTHECON
- —POLYCILLINBrand (NDA)
NDA 050308 · BRISTOL
- —POLYCILLINBrand (NDA)
NDA 050093 · BRISTOL
- 2023AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 216554 · AUROBINDO PHARMA
- 1995AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 064082 · SANDOZ
- 1989AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 062982 · PH HEALTH
- 1988PRINCIPENGeneric (ANDA)
ANDA 062888 · APOTHECON
- 1988AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 062883 · STRIDES PHARMA INTL
- 1988AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 062882 · STRIDES PHARMA INTL
- —AMCILLGeneric (ANDA)
ANDA 062041 · PARKE DAVIS
- —AMPICILLIN TRIHYDRATEGeneric (ANDA)
ANDA 061602 · BELCHER PHARMS
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.
