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FDA Orange Book · active-ingredient family

Penicillin g benzathine

Penicillin g benzathine is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BICILLIN L-A · NDA 050141

5

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, suspension, tablet

ProductApplicantApplicationTEApproved
BICILLIN L-ARLD×2KING PHARMS LLCNDA 050141Approved Prior to Jan 1, 1982
BICILLIN L-AWYETH AYERSTNDA 050131Approved Prior to Jan 1, 1982
PERMAPENCASPER PHARMA LLCNDA 060014Approved Prior to Jan 1, 1982
BICILLINWYETH AYERSTNDA 050126Approved Prior to Jan 1, 1982
BICILLINWYETH AYERSTNDA 050128Approved 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 benzathine — 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.