Orange Book product · Brand (NDA)
GYNE-LOTRIMIN COMBINATION PACK
CLOTRIMAZOLE
At a glance
Apr 26, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 1993
33 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOTRIMAZOLE
Strength
1%,100MG
Dosage form
CREAM, TABLET
Route
TOPICAL, VAGINAL
TE code
Not listed
Application
NDA 020289
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
- 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
- 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.
