Assyro AI

FDA Orange Book · active-ingredient family

Penicillin v potassium

Penicillin v potassium is approved in 36 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

36

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (36)

ProductApplicantApplicationTEApproved
PENICILLIN V POTASSIUM×2HIKMA PHARMSANDA 090549ABOct 11, 2013
PENICILLIN V POTASSIUM×2AUROBINDO PHARMAANDA 065435ABApr 29, 2008
PENICILLIN V POTASSIUM×2SANDOZANDA 064071—Nov 30, 1995
PENICILLIN V POTASSIUM×2CHARTWELL RXANDA 062981—Feb 10, 1989
PENICILLIN V POTASSIUMCHARTWELL RXANDA 062936ABNov 25, 1988
PENICILLIN V POTASSIUMCHARTWELL RXANDA 062935ABNov 23, 1988
BEEPEN-VK×2GLAXOSMITHKLINEANDA 062270—Approved Prior to Jan 1, 1982
BETAPEN-VK×2APOTHECONANDA 061149—Approved Prior to Jan 1, 1982
LEDERCILLIN VK×2LEDERLEANDA 060136—Approved Prior to Jan 1, 1982
PEN-VEE K×2WYETH AYERSTANDA 060007—Approved Prior to Jan 1, 1982
PENAPAR-VK×2PARKE DAVISANDA 062002—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×2BELCHER PHARMSANDA 061529—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×2MYLANANDA 061624—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×2PUREPAC PHARMANDA 061758—Approved Prior to Jan 1, 1982
PENICILLIN-VK×2TEVAANDA 060456—Approved Prior to Jan 1, 1982
PFIZERPEN VK×2PFIZERANDA 061815—Approved Prior to Jan 1, 1982
V-CILLIN K×2LILLYANDA 060004—Approved Prior to Jan 1, 1982
VEETIDS×2APOTHECONANDA 061410—Approved Prior to Jan 1, 1982
VEETIDS '125'×2APOTHECONANDA 061206—Approved Prior to Jan 1, 1982
VEETIDS '125'×2APOTHECONANDA 062153—Approved Prior to Jan 1, 1982
BEEPEN-VK×2GLAXOSMITHKLINEANDA 062273—Approved Prior to Jan 1, 1982
BETAPEN-VK×2BRISTOLANDA 061150—Approved Prior to Jan 1, 1982
LEDERCILLIN VK×2LEDERLEANDA 060134—Approved Prior to Jan 1, 1982
PEN-VEE K×3WYETH AYERSTANDA 060006—Approved Prior to Jan 1, 1982
PENAPAR-VK×2PARKE DAVISANDA 062001—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×2BELCHER PHARMSANDA 061528—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×3IVAX SUB TEVA PHARMSANDA 060518—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×2MYLANANDA 061530—Approved Prior to Jan 1, 1982
PENICILLIN V POTASSIUM×3PUREPAC PHARMANDA 061571—Approved Prior to Jan 1, 1982
PENICILLIN-VK×2TEVAANDA 060711ABApproved Prior to Jan 1, 1982
PFIZERPEN VK×2PFIZERANDA 061836—Approved Prior to Jan 1, 1982
UTICILLIN VK×2PHARMACIA AND UPJOHNANDA 061651—Approved Prior to Jan 1, 1982
V-CILLIN K×3LILLYANDA 060003—Approved Prior to Jan 1, 1982
VEETIDS×2APOTHECONANDA 061411—Approved Prior to Jan 1, 1982
VEETIDS '250'×2APOTHECONANDA 061164—Approved Prior to Jan 1, 1982
VEETIDS '250'×2APOTHECONANDA 062156—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.

Penicillin v 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.

Book a Demo