Assyro AI

FDA Orange Book · active-ingredient family

Penicillin g procaine

Penicillin g procaine is approved in 6 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

6

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
DURACILLIN A.S.LILLYANDA 060093Approved Prior to Jan 1, 1982
PENICILLIN G PROCAINE×2CONSOLIDATED PHARMANDA 060800Approved Prior to Jan 1, 1982
PENICILLIN G PROCAINE×2KING PHARMS LLCANDA 060101Approved Prior to Jan 1, 1982
PENICILLIN G PROCAINEPARKE DAVISANDA 062029Approved Prior to Jan 1, 1982
PENICILLIN G PROCAINE×2PFIZERANDA 060099Approved Prior to Jan 1, 1982
PFIZERPEN-AS×2PFIZERANDA 060286Approved 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 procaine — 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.