Orange Book product · Generic (ANDA)
NYSTATIN
NYSTATIN
At a glance
Feb 05, 2026
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
NYSTATIN
Strength
100,000 UNITS/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AA
Application
ANDA 220367
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NYSTATIN
- 1987MYCOSTATINBrand (NDA)
NDA 050619 · DELCOR ASSET CORP
- 1983NILSTATBrand (NDA)
NDA 050576 · STRIDES PHARMA INTL
- —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
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.
