Orange Book product · Generic (ANDA)
AMPICILLIN TRIHYDRATE
AMPICILLIN/AMPICILLIN TRIHYDRATE
At a glance
Oct 31, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Strength
EQ 250MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 216554
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPICILLIN/AMPICILLIN TRIHYDRATE
- —POLYCILLINBrand (NDA)
NDA 050310 · BRISTOL
- —PRINCIPEN '250'Brand (NDA)
NDA 050056 · APOTHECON
- —PENBRITINBrand (NDA)
NDA 050019 · WYETH AYERST
- —POLYCILLINBrand (NDA)
NDA 050308 · BRISTOL
- —POLYCILLINBrand (NDA)
NDA 050093 · BRISTOL
- 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.
