FDA Orange Book · active-ingredient family
Prazosin hydrochloride
Prazosin hydrochloride is approved as 2 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MINIPRESS · NDA 017442
2
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MINIPRESSRLD×3 | PFIZER | NDA 017442 | AB | Approved Prior to Jan 1, 1982 | |
| MINIPRESS XL×2 | PFIZER | NDA 019775 | — | Jan 29, 1992 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRAZOSIN HYDROCHLORIDE×3 | MSN | ANDA 216727 | AB | Sep 17, 2024 | |
| PRAZOSIN HYDROCHLORIDE×3 | LANNETT CO INC | ANDA 214083 | — | Jan 03, 2024 | |
| PRAZOSIN HYDROCHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 213052 | AB | Mar 31, 2023 | |
| PRAZOSIN HYDROCHLORIDE×3 | ALEMBIC | ANDA 217268 | AB | Mar 06, 2023 | |
| PRAZOSIN HYDROCHLORIDE×3 | MANKIND PHARMA | ANDA 215697 | AB | Dec 30, 2022 | |
| PRAZOSIN HYDROCHLORIDE×3 | APPCO | ANDA 213406 | AB | Oct 21, 2022 | |
| PRAZOSIN HYDROCHLORIDE×3 | GRANULES | ANDA 214608 | AB | Dec 23, 2021 | |
| PRAZOSIN HYDROCHLORIDE×3 | NOVITIUM PHARMA | ANDA 210971 | AB | Oct 03, 2018 | |
| PRAZOSIN HYDROCHLORIDE | AM THERAP | ANDA 072782 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | AM THERAP | ANDA 072783 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | AM THERAP | ANDA 072784 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE×3 | ANI PHARMS | ANDA 072577 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | DAVA PHARMS INC | ANDA 072705 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | DAVA PHARMS INC | ANDA 072706 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | DAVA PHARMS INC | ANDA 072707 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE×3 | MYLAN | ANDA 072575 | AB | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | PUREPAC PHARM | ANDA 072991 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | PUREPAC PHARM | ANDA 072921 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | PUREPAC PHARM | ANDA 072992 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | WATSON LABS | ANDA 072352 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | WATSON LABS | ANDA 072333 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE | WATSON LABS | ANDA 072609 | — | May 16, 1989 | |
| PRAZOSIN HYDROCHLORIDE×3 | TEVA PHARMS | ANDA 071745 | AB | Sep 12, 1988 |
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.
Prazosin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
