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
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMPAZINERLD×3 | GLAXOSMITHKLINE | NDA 011127 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROCHLORPERAZINE×3 | ABLE | ANDA 040407 | — | Jul 11, 2001 | |
| COMPRO | PADAGIS US | ANDA 040246 | AB | Jun 28, 2000 | |
| PROCHLORPERAZINE | COSETTE PHARMS NC | ANDA 040058 | AB | Nov 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.

