Orange Book product · Generic (ANDA)
NYSTATIN
NYSTATIN
At a glance
Mar 21, 2025
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NYSTATIN
Strength
100,000 UNITS/GM
Dosage form
CREAM
Route
TOPICAL
TE code
AT
Application
ANDA 219527
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
- 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.
