Orange Book product · Generic (ANDA)
NYSTATIN
NYSTATIN
At a glance
Dec 27, 1991
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
NYSTATIN
Strength
100,000 UNITS/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AA
Application
ANDA 062832
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.
