Orange Book product · Generic (ANDA)
METRONIDAZOLE
METRONIDAZOLE
At a glance
Oct 14, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 14, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
METRONIDAZOLE
Strength
0.75%
Dosage form
GEL
Route
VAGINAL
TE code
AB
Application
ANDA 213648
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METRONIDAZOLE
- 2014NUVESSABrand (NDA)
NDA 205223 · ALEMBIC THERAP
- 2005METROGELBrand (NDA)
NDA 021789 · GALDERMA LABS LP
- 2005VANDAZOLEBrand (NDA)
NDA 021806 · TEVA PHARMS
- 1998METROLOTIONBrand (NDA)
NDA 020901 · GALDERMA LABS LP
- 1997NORITATEBrand (NDA)
NDA 020743 · BAUSCH
- 1995METROCREAMBrand (NDA)
NDA 020531 · GALDERMA LABS LP
- 1995FLAGYLBrand (NDA)
NDA 020334 · PFIZER
- 1992METROGEL-VAGINALBrand (NDA)
NDA 020208 · BAUSCH
- 1988METROGELBrand (NDA)
NDA 019737 · GALDERMA LABS LP
- 1984METRONIDAZOLEBrand (NDA)
NDA 018907 · HIKMA
- 1983METRONIDAZOLEBrand (NDA)
NDA 018889 · ABBOTT
- 1983METRONIDAZOLE IN PLASTIC CONTAINERBrand (NDA)
NDA 018890 · HOSPIRA
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.
