Orange Book product · Generic (ANDA)
ACETIC ACID
ACETIC ACID, GLACIAL
At a glance
Mar 09, 2018
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 09, 2018
8 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETIC ACID, GLACIAL
Strength
2%
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
AT
Application
ANDA 207280
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETIC ACID, GLACIAL
- 1982ACETIC ACID 0.25% IN PLASTIC CONTAINERBrand (NDA)
NDA 018523 · BAXTER HLTHCARE
- —VOSOLBrand (NDA)
NDA 012179 · HIKMA
- —ACETIC ACID 0.25% IN PLASTIC CONTAINERBrand (NDA)
NDA 018161 · B BRAUN
- —ACETIC ACID 0.25% IN PLASTIC CONTAINERBrand (NDA)
NDA 017656 · OTSUKA ICU MEDCL
- 2005ACETIC ACIDGeneric (ANDA)
ANDA 040607 · SCIEGEN PHARMS
- 1996ACETIC ACIDGeneric (ANDA)
ANDA 040166 · CHARTWELL RX
- 1984ACETIC ACIDGeneric (ANDA)
ANDA 088638 · SUN PHARMA CANADA
- —ACETASOLGeneric (ANDA)
ANDA 087146 · ACTAVIS MID ATLANTIC
- —ACETIC ACIDGeneric (ANDA)
ANDA 085493 · KV PHARM
- —ORLEXGeneric (ANDA)
ANDA 086845 · WARNER CHILCOTT
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.
