Assyro AI

FDA Orange Book · active-ingredient family

Penicillin g potassium

Penicillin g potassium is approved as 1 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

1

Brand (NDA)

26

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution, injectable, tablet

ProductApplicantApplicationTEApproved
PENICILLIN G POTASSIUM IN PLASTIC CONTAINERRLD×3BAXTER HLTHCARENDA 050638Jun 25, 1990

Generic (ANDA) products (26)

ProductApplicantApplicationTEApproved
PENICILLIN G POTASSIUM×2ACS DOBFAR SPAANDA 205043APOct 26, 2018
PENICILLIN G POTASSIUM×2ISTITUTO BIO ITA SPAANDA 065448APAug 18, 2009
PENICILLIN G POTASSIUM×3HQ SPECLT PHARMAANDA 065149Jul 23, 2009
PENICILLIN G POTASSIUM×3SANDOZANDA 065079Aug 30, 2002
PENICILLIN G POTASSIUM×4WATSON LABS INCANDA 062991Sep 13, 1988
PENICILLIN×3TEVAANDA 060307Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×3MYLANANDA 060752Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×2PUREPAC PHARMANDA 061740Approved Prior to Jan 1, 1982
PENTIDS '200'×2APOTHECONANDA 062149Approved Prior to Jan 1, 1982
PFIZERPEN GPFIZERANDA 060587Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×4APOTHECONANDA 060362Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×4CONSOLIDATED PHARMANDA 060806Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×5LILLYANDA 060384Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUMLILLYANDA 060601Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×2PARKE DAVISANDA 062003Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUMPFIZERANDA 060074Approved Prior to Jan 1, 1982
PFIZERPEN×3PFIZERANDA 060657Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×3APOTHECONANDA 060392Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUMIVAX SUB TEVA PHARMSANDA 060073Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUMLILLYANDA 060403Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×5MYLANANDA 060781Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×3PUREPAC PHARMANDA 061588Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×4TEVAANDA 060306Approved Prior to Jan 1, 1982
PENICILLIN G POTASSIUM×3WYETH AYERSTANDA 060413Approved Prior to Jan 1, 1982
PENTIDS '200'×4APOTHECONANDA 062155Approved Prior to Jan 1, 1982
PFIZERPEN G×6PFIZERANDA 060075Approved 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.

Penicillin g potassium — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.