FDA Orange Book · active-ingredient family
Propylthiouracil
Propylthiouracil is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROPYLTHIOURACIL · NDA 006188
2
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPYLTHIOURACILRLD | PH HEALTH | NDA 006188 | AB | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | LILLY | NDA 006213 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPYLTHIOURACIL | MACLEODS PHARMS LTD | ANDA 208867 | AB | May 10, 2023 | |
| PROPYLTHIOURACIL | ABBOTT | ANDA 084075 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | ACTAVIS ELIZABETH | ANDA 080172 | BD | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | ANABOLIC | ANDA 080285 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | ANI PHARMS | ANDA 080215 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | CHARTWELL MOLECULAR | ANDA 080016 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | CHARTWELL RX | ANDA 084543 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | HALSEY | ANDA 080015 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | IMPAX LABS | ANDA 080159 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | QUAGEN | ANDA 080154 | BD | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | SUN PHARM INDUSTRIES | ANDA 083982 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | TABLICAPS | ANDA 080840 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | WATSON LABS | ANDA 080932 | — | Approved Prior to Jan 1, 1982 | |
| PROPYLTHIOURACIL | WATSON LABS | ANDA 085201 | — | Approved 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.
Propylthiouracil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
