Orange Book product · Generic (ANDA)
MYCOSTATIN
NYSTATIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NYSTATIN
Strength
100,000 UNITS/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 061533
Product number
001
Marketing status
DISCN
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.
