FDA Orange Book · active-ingredient family
Acetic acid, glacial
Acetic acid, glacial is approved as 4 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VOSOL · NDA 012179
4
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOSOLRLD | HIKMA | NDA 012179 | — | Approved Prior to Jan 1, 1982 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 017656 | AT | Approved Prior to Jan 1, 1982 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 018523 | AT | Feb 19, 1982 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | B BRAUN | NDA 018161 | AT | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETIC ACID | RISING | ANDA 207280 | AT | Mar 09, 2018 | |
| ACETIC ACID | SCIEGEN PHARMS | ANDA 040607 | AT | Feb 24, 2005 | |
| ACETIC ACID | CHARTWELL RX | ANDA 040166 | — | Jul 26, 1996 | |
| ACETIC ACID | SUN PHARMA CANADA | ANDA 088638 | — | Sep 06, 1984 | |
| ACETASOL | ACTAVIS MID ATLANTIC | ANDA 087146 | — | Approved Prior to Jan 1, 1982 | |
| ACETIC ACID | KV PHARM | ANDA 085493 | — | Approved Prior to Jan 1, 1982 | |
| ORLEX | WARNER CHILCOTT | ANDA 086845 | — | Approved Prior to Jan 1, 1982 |
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.
Acetic acid, glacial — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
