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FDA Orange Book · active-ingredient family

Ampicillin/ampicillin trihydrate

Ampicillin/ampicillin trihydrate is approved as 5 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PRINCIPEN '250' · NDA 050056

5

Brand (NDA)

34

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, for suspension, tablet, chewable

ProductApplicantApplicationTEApproved
PRINCIPEN '250'RLD×2APOTHECONNDA 050056—Approved Prior to Jan 1, 1982
POLYCILLIN×2BRISTOLNDA 050310—Approved Prior to Jan 1, 1982
PENBRITIN×3WYETH AYERSTNDA 050019—Approved Prior to Jan 1, 1982
POLYCILLIN×4BRISTOLNDA 050308—Approved Prior to Jan 1, 1982
POLYCILLINBRISTOLNDA 050093—Approved Prior to Jan 1, 1982

Generic (ANDA) products (34)

ProductApplicantApplicationTEApproved
AMPICILLIN TRIHYDRATE×2AUROBINDO PHARMAANDA 216554—Oct 31, 2023
AMPICILLIN TRIHYDRATE×2SANDOZANDA 064082—Aug 29, 1995
AMPICILLIN TRIHYDRATE×2PH HEALTHANDA 062982—Feb 10, 1989
PRINCIPEN×2APOTHECONANDA 062888—Mar 04, 1988
AMPICILLIN TRIHYDRATESTRIDES PHARMA INTLANDA 062883—Feb 25, 1988
AMPICILLIN TRIHYDRATESTRIDES PHARMA INTLANDA 062882—Feb 25, 1988
AMCILL×2PARKE DAVISANDA 062041—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2BELCHER PHARMSANDA 061602—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2CHARTWELL RXANDA 061502—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2IVAX SUB TEVA PHARMSANDA 060765—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2LEDERLEANDA 062208—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2MYLANANDA 061755—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2PUREPAC PHARMANDA 061853—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2VITARINEANDA 061387—Approved Prior to Jan 1, 1982
OMNIPEN (AMPICILLIN)×2WYETH AYERSTANDA 060624—Approved Prior to Jan 1, 1982
PENBRITIN×2WYETH AYERSTANDA 060908—Approved Prior to Jan 1, 1982
PFIZERPEN-A×2PFIZERANDA 062050—Approved Prior to Jan 1, 1982
PRINCIPEN×2BRISTOL MYERS SQUIBBANDA 061392—Approved Prior to Jan 1, 1982
PRINCIPEN '250'×2APOTHECONANDA 062157—Approved Prior to Jan 1, 1982
TOTACILLIN×2GLAXOSMITHKLINEANDA 060060—Approved Prior to Jan 1, 1982
TOTACILLIN×2GLAXOSMITHKLINEANDA 062212—Approved Prior to Jan 1, 1982
AMCILL×2PARKE DAVISANDA 062030—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2BELCHER PHARMSANDA 061601—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2MYLANANDA 061829—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2PUREPAC PHARMANDA 061980—Approved Prior to Jan 1, 1982
AMPICILLIN TRIHYDRATE×2TEVAANDA 061370—Approved Prior to Jan 1, 1982
OMNIPEN (AMPICILLIN)×4WYETH AYERSTANDA 060625—Approved Prior to Jan 1, 1982
PFIZERPEN-A×2PFIZERANDA 062049—Approved Prior to Jan 1, 1982
POLYCILLIN×2APOTHECONANDA 062297—Approved Prior to Jan 1, 1982
PRINCIPEN×3APOTHECONANDA 061394—Approved Prior to Jan 1, 1982
PRINCIPEN '125'×2APOTHECONANDA 060127—Approved Prior to Jan 1, 1982
PRINCIPEN '125'×2APOTHECONANDA 062151—Approved Prior to Jan 1, 1982
TOTACILLIN×2GLAXOSMITHKLINEANDA 060666—Approved Prior to Jan 1, 1982
TOTACILLIN×2GLAXOSMITHKLINEANDA 062223—Approved Prior to Jan 1, 1982

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.

Ampicillin/ampicillin trihydrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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