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FDA Orange Book · active-ingredient family

Prochlorperazine

Prochlorperazine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:COMPAZINE · NDA 011127

1

Brand (NDA)

3

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · suppository

ProductApplicantApplicationTEApproved
COMPAZINERLD×3GLAXOSMITHKLINENDA 011127Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
PROCHLORPERAZINE×3ABLEANDA 040407Jul 11, 2001
COMPROPADAGIS USANDA 040246ABJun 28, 2000
PROCHLORPERAZINECOSETTE PHARMS NCANDA 040058ABNov 24, 1993

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.

Prochlorperazine — 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.