FDA Orange Book · active-ingredient family
Nystatin
Nystatin is approved as 5 brand and 76 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NILSTAT · NDA 050576
5
Brand (NDA)
76
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, ointment, pastille, powder, suppository, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NILSTATRLD | STRIDES PHARMA INTL | NDA 050576 | — | Dec 22, 1983 | |
| NILSTATRLD | CHARTWELL MOLECULES | NDA 050299 | AA | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | NDA 050619 | — | Apr 09, 1987 | |
| CANDEX | BAYER PHARMS | NDA 050233 | — | Approved Prior to Jan 1, 1982 | |
| NYSERT | WARNER CHILCOTT | NDA 050478 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (76)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NYSTATIN | STERANCO HLTHCARE | ANDA 220367 | AA | Feb 05, 2026 | |
| NYSTATIN | AUROBINDO PHARMA | ANDA 219527 | AT | Mar 21, 2025 | |
| NYSTATIN | SENORES PHARMS | ANDA 214346 | AA | Mar 10, 2022 | |
| NYSTATIN | MACLEODS PHARMS LTD | ANDA 213566 | AT | Aug 10, 2021 | |
| NYSTATIN | MACLEODS PHARMS LTD | ANDA 213826 | AT | Jan 14, 2021 | |
| NYSTATIN | TORRENT | ANDA 212557 | AT | Jul 24, 2019 | |
| NYSTATIN | TORRENT | ANDA 211838 | AT | Jan 28, 2019 | |
| NYSTATIN | ZYDUS LIFESCIENCES | ANDA 207767 | AT | May 25, 2018 | |
| NYSTATIN | LYNE | ANDA 209082 | AT | May 21, 2018 | |
| KLAYESTA | EPIC PHARMA LLC | ANDA 210532 | AT | Apr 30, 2018 | |
| NYSTATIN | COSETTE | ANDA 209114 | AT | Oct 06, 2017 | |
| NYSTATIN | CROWN LABS INC | ANDA 207733 | AT | Sep 26, 2017 | |
| NYSTATIN | ZYDUS PHARMS | ANDA 208581 | AT | Jun 08, 2017 | |
| NYSTATIN | LYNE | ANDA 208838 | AT | May 30, 2017 | |
| NYSTATIN | PHARM ASSOC | ANDA 203621 | AA | Jan 07, 2016 | |
| NYSTATIN | NESHER PHARMS | ANDA 065321 | — | Aug 18, 2006 | |
| NYSTATIN | CHARTWELL RX | ANDA 065315 | — | May 31, 2006 | |
| NYSTATIN | GENUS | ANDA 065148 | AA | Jun 28, 2005 | |
| NYSTATIN | UPSHER SMITH LABS | ANDA 065183 | AT | May 03, 2005 | |
| NYSTATIN | PHARMOBEDIENT | ANDA 065175 | — | Dec 17, 2004 | |
| NYSTATIN | LUPIN | ANDA 065138 | AT | Jul 23, 2004 | |
| NYSTATIN | DR REDDYS LABS SA | ANDA 065203 | AT | Jul 15, 2004 | |
| NYSTATIN×2 | VISTAPHARM LLC | ANDA 064142 | — | Jun 25, 1998 | |
| NYSTOP | PADAGIS US | ANDA 064118 | AT | Aug 16, 1996 | |
| NYSTATIN | PAI HOLDINGS | ANDA 064042 | — | Feb 28, 1994 | |
| NYSTATIN | SUN PHARMA CANADA | ANDA 064022 | AT | Jan 29, 1993 | |
| NYSTATIN | SCIEGEN PHARMS | ANDA 062832 | AA | Dec 27, 1991 | |
| NYSTATIN | SUN PHARM INDUSTRIES | ANDA 062838 | — | Dec 22, 1988 | |
| NYSTATIN | ACTAVIS MID ATLANTIC | ANDA 062949 | AT | Jun 13, 1988 | |
| BARSTATIN 100 | BARLAN | ANDA 062489 | — | Apr 27, 1988 | |
| NYSTATIN | TARO | ANDA 062876 | — | Feb 29, 1988 | |
| NYSTATIN | COSETTE | ANDA 062776 | — | Dec 17, 1987 | |
| NYSTATIN | MORTON GROVE | ANDA 062835 | — | Nov 19, 1987 | |
| NYSTATIN | ACTAVIS MID ATLANTIC | ANDA 062840 | AT | Nov 13, 1987 | |
| NYSTATIN | TEVA | ANDA 062670 | — | Jun 18, 1987 | |
| MYKINAC | ALPHARMA US PHARMS | ANDA 062731 | — | Sep 22, 1986 | |
| NYSTATIN | PADDOCK LLC | ANDA 062613 | — | Nov 26, 1985 | |
| NYSTATIN | CHARTWELL RX | ANDA 062524 | — | Nov 26, 1985 | |
| NYSTATIN | ALPHARMA US PHARMS | ANDA 062571 | — | Oct 29, 1985 | |
| NYSTATIN | ODYSSEY PHARMS | ANDA 062615 | — | Oct 17, 1985 | |
| NYSTATIN | PHARMAFAIR | ANDA 062541 | — | Jan 16, 1985 | |
| NYSTATIN | PHARMOBEDIENT | ANDA 062512 | AA | Oct 29, 1984 | |
| NYSTATIN | QUANTUM PHARMICS | ANDA 062525 | — | Oct 29, 1984 | |
| NYSTATIN | PHARMADERM | ANDA 062518 | — | Jul 06, 1984 | |
| NYSTEX | SAVAGE LABS | ANDA 062519 | — | Jul 06, 1984 | |
| NYSTATIN | FOUGERA PHARMS INC | ANDA 062517 | AA | Jun 07, 1984 | |
| NYSTATIN | QUANTUM PHARMICS | ANDA 062509 | — | Apr 03, 1984 | |
| NYSTATIN | PADAGIS US | ANDA 062472 | AT | Feb 13, 1984 | |
| NYSTATIN | TEVA | ANDA 062506 | AA | Jan 16, 1984 | |
| NYSTATIN | TEVA | ANDA 062502 | — | Dec 23, 1983 | |
| NYSTATIN | HERITAGE | ANDA 062474 | AA | Dec 22, 1983 | |
| NYSTATIN | FOUGERA | ANDA 062459 | — | Nov 09, 1983 | |
| NYSTATIN | PHARMADERM | ANDA 062460 | — | Nov 09, 1983 | |
| NYSTATIN | SUN PHARMA CANADA | ANDA 062457 | — | Jul 28, 1983 | |
| NYSTATIN | WATSON LABS | ANDA 062402 | — | Dec 16, 1982 | |
| NYSTATIN | FOUGERA PHARMS | ANDA 062124 | AT | Sep 23, 1982 | |
| MYKINAC | ALPHARMA US PHARMS | ANDA 062387 | — | Jul 29, 1982 | |
| NYSTATIN | G AND W LABS INC | ANDA 062349 | — | Jul 14, 1982 | |
| CANDEX | BAYER PHARMS | ANDA 061810 | — | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 060575 | — | Approved Prior to Jan 1, 1982 | |
| NILSTAT | LEDERLE | ANDA 061445 | — | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | COSETTE PHARMS NC | ANDA 061966 | AT | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | FOUGERA PHARMS | ANDA 062129 | AT | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | PADAGIS US | ANDA 062225 | AT | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 060571 | — | Approved Prior to Jan 1, 1982 | |
| NILSTAT | LEDERLE | ANDA 061444 | — | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 060578 | — | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 061533 | — | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 060574 | — | Approved Prior to Jan 1, 1982 | |
| NILSTAT | LEDERLE | ANDA 061151 | — | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | SANDOZ | ANDA 062065 | — | Approved Prior to Jan 1, 1982 | |
| KOROSTATIN | HOLLAND RANTOS | ANDA 061718 | — | Approved Prior to Jan 1, 1982 | |
| MYCOSTATIN | DELCOR ASSET CORP | ANDA 060577 | — | Approved Prior to Jan 1, 1982 | |
| NILSTAT | LEDERLE | ANDA 061325 | — | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | SANDOZ | ANDA 061965 | — | Approved Prior to Jan 1, 1982 | |
| NYSTATIN | WATSON LABS | ANDA 062176 | — | 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.
Nystatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
