FDA Orange Book · active-ingredient family
Doxazosin mesylate
Doxazosin mesylate is approved as 2 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARDURA XL · NDA 021269
2
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARDURA XLRLD×2 | VIATRIS | NDA 021269 | — | Feb 22, 2005 | |
| CARDURARLD×4 | VIATRIS | NDA 019668 | AB | Nov 02, 1990 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOXAZOSIN MESYLATE×4 | UNICHEM | ANDA 212329 | AB | Jan 10, 2024 | |
| DOXAZOSIN MESYLATE×4 | RISING | ANDA 212727 | AB | Mar 15, 2022 | |
| DOXAZOSIN MESYLATE×4 | SOMERSET THERAPS LLC | ANDA 209013 | AB | Apr 17, 2018 | |
| DOXAZOSIN MESYLATE×4 | HERITAGE PHARMA | ANDA 205210 | AB | Feb 13, 2018 | |
| DOXAZOSIN MESYLATE×4 | ZYDUS PHARMS | ANDA 208719 | AB | Jul 07, 2017 | |
| DOXAZOSIN MESYLATE×4 | ACCORD HLTHCARE | ANDA 202824 | AB | Jun 11, 2014 | |
| DOXAZOSIN MESYLATE×4 | STRIDES PHARMA INTL | ANDA 076161 | — | Jun 10, 2004 | |
| DOXAZOSIN MESYLATE×4 | PLIVA | ANDA 075750 | — | Jun 08, 2001 | |
| DOXAZOSIN MESYLATE×4 | TEVA | ANDA 075353 | — | Jan 12, 2001 | |
| DOXAZOSIN MESYLATE×4 | AUROBINDO PHARMA USA | ANDA 075509 | AB | Oct 19, 2000 | |
| DOXAZOSIN MESYLATE×4 | ACTAVIS ELIZABETH | ANDA 075574 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | ANI PHARMS | ANDA 075432 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | APOTEX | ANDA 075580 | AB | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | CHARTWELL RX | ANDA 075646 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | GENPHARM | ANDA 075466 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | IVAX SUB TEVA PHARMS | ANDA 075453 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | NESHER PHARMS | ANDA 075609 | — | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | TEVA | ANDA 075536 | AB | Oct 18, 2000 | |
| DOXAZOSIN MESYLATE×4 | WATSON LABS INC | ANDA 075426 | — | Oct 18, 2000 |
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.
Doxazosin mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
