FDA Orange Book · active-ingredient family
Acetic acid, glacial; hydrocortisone
Acetic acid, glacial; hydrocortisone is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VOSOL HC · NDA 012770
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOSOL HCRLD | SAPTALIS PHARMS | NDA 012770 | AT | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCORTISONE AND ACETIC ACID | COSETTE PHARMS NC | ANDA 040609 | AT | Feb 06, 2006 | |
| HYDROCORTISONE AND ACETIC ACID | WOCKHARDT | ANDA 040168 | — | Aug 30, 1996 | |
| HYDROCORTISONE AND ACETIC ACID | BAUSCH AND LOMB | ANDA 040097 | — | Oct 31, 1994 | |
| HYDROCORTISONE AND ACETIC ACIDRLD | TARO | ANDA 088759 | AT | Mar 04, 1985 | |
| ACETASOL HC | ACTAVIS MID ATLANTIC | ANDA 087143 | — | Jan 13, 1982 | |
| ACETIC ACID W/ HYDROCORTISONE | KV PHARM | ANDA 085492 | — | Approved Prior to Jan 1, 1982 | |
| ORLEX HC | WARNER CHILCOTT | ANDA 086844 | — | 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; hydrocortisone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
