Orange Book product · Generic (ANDA)
CLOTRIMAZOLE
CLOTRIMAZOLE
At a glance
Oct 16, 2023
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOTRIMAZOLE
Strength
1%
Dosage form
SOLUTION
Route
TOPICAL
TE code
AT
Application
ANDA 216569
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLOTRIMAZOLE
- 2025CLOTICBrand (NDA)
NDA 217628 · CARWIN PHARM ASSOC
- 2000TRIVAGIZOLE 3Brand (NDA)
NDA 021143 · SUN PHARMA CANADA
- 1998GYNE-LOTRIMIN 3Brand (NDA)
NDA 020574 · BAYER HEALTHCARE LLC
- 1996GYNE-LOTRIMIN 3 COMBINATION PACKBrand (NDA)
NDA 020526 · BAYER HEALTHCARE LLC
- 1996GYNE-LOTRIMIN 3Brand (NDA)
NDA 020525 · BAYER HEALTHCARE LLC
- 1994MYCELEX-7 COMBINATION PACKBrand (NDA)
NDA 020389 · BAYER HEALTHCARE LLC
- 1993GYNE-LOTRIMIN COMBINATION PACKBrand (NDA)
NDA 020289 · BAYER HEALTHCARE LLC
- 1991MYCELEX-7Brand (NDA)
NDA 018230 · BAYER HEALTHCARE LLC
- 1991MYCELEX-7Brand (NDA)
NDA 018182 · BAYER HEALTHCARE LLC
- 1990GYNE-LOTRIMINBrand (NDA)
NDA 018052 · BAYER HEALTHCARE LLC
- 1990GYNE-LOTRIMINBrand (NDA)
NDA 017717 · BAYER HEALTHCARE LLC
- 1985MYCELEX-GBrand (NDA)
NDA 019069 · BAYER PHARMS
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.
