Orange Book product · Brand (NDA)
GYNE-LOTRIMIN
CLOTRIMAZOLE
At a glance
Nov 30, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 1990
36 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOTRIMAZOLE
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
NDA 018052
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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 017717 · BAYER HEALTHCARE LLC
- 1985MYCELEX-GBrand (NDA)
NDA 019069 · BAYER PHARMS
- 1984LOTRIMINBrand (NDA)
NDA 018813 · SCHERING
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.
