Orange Book product · Generic (ANDA)
METRONIDAZOLE
METRONIDAZOLE
At a glance
Oct 29, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
METRONIDAZOLE
Strength
125MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 070772
Product number
003
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.
