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FDA Orange Book · active-ingredient family

Povidone-iodine

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

Reference-listed drug:POVIDONE IODINE · NDA 019522

5

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, solution/drops, sponge

ProductApplicantApplicationTEApproved
POVIDONE IODINERLDALLEGIANCE HLTHCARENDA 019522Mar 31, 1989
E-Z SCRUB 241RLDBECTON DICKINSONNDA 019476Jan 07, 1987
BETADINERLDALCON PHARMS LTDNDA 018634Dec 17, 1986
E-Z SCRUB 201RLDBECTON DICKINSONNDA 019240Nov 29, 1985
E-Z PREP×3CLINIPADNDA 019382Jul 25, 1989

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.

Povidone-iodine — 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.