Orange Book product · Brand (NDA)
NILSTAT
NYSTATIN
At a glance
Dec 22, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1983
43 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
NYSTATIN
Strength
100% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
POWDER
Route
ORAL
TE code
Not listed
Application
NDA 050576
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1987MYCOSTATINBrand (NDA)
NDA 050619 · DELCOR ASSET CORP
- —CANDEXBrand (NDA)
NDA 050233 · BAYER PHARMS
- —NYSERTBrand (NDA)
NDA 050478 · WARNER CHILCOTT
- —NILSTATBrand (NDA)
NDA 050299 · CHARTWELL MOLECULES
- 2025NYSTATINGeneric (ANDA)
ANDA 219527 · AUROBINDO PHARMA
- 2021NYSTATINGeneric (ANDA)
ANDA 213566 · MACLEODS PHARMS LTD
- 2021NYSTATINGeneric (ANDA)
ANDA 213826 · MACLEODS PHARMS LTD
- 2019NYSTATINGeneric (ANDA)
ANDA 212557 · TORRENT
- 2019NYSTATINGeneric (ANDA)
ANDA 211838 · TORRENT
- 2018NYSTATINGeneric (ANDA)
ANDA 207767 · ZYDUS LIFESCIENCES
- 2018NYSTATINGeneric (ANDA)
ANDA 209082 · LYNE
- 2018KLAYESTAGeneric (ANDA)
ANDA 210532 · EPIC PHARMA LLC
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.
