Orange Book product · Brand (NDA)
METROLOTION
METRONIDAZOLE
At a glance
Nov 24, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 1998
28 yr ago
Today
Pharmaceutical detail
Active ingredient
METRONIDAZOLE
Strength
0.75%
Dosage form
LOTION
Route
TOPICAL
TE code
AB
Application
NDA 020901
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2014NUVESSABrand (NDA)
NDA 205223 · ALEMBIC THERAP
- 2005METROGELBrand (NDA)
NDA 021789 · GALDERMA LABS LP
- 2005VANDAZOLEBrand (NDA)
NDA 021806 · TEVA PHARMS
- 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
- 1983METRO I.V. IN PLASTIC CONTAINERBrand (NDA)
NDA 018900 · B BRAUN
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.
