Orange Book product · Generic (ANDA)
HYDROCORTISONE AND ACETIC ACID
ACETIC ACID, GLACIAL; HYDROCORTISONE
At a glance
Mar 04, 1985
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 1985
41 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETIC ACID, GLACIAL; HYDROCORTISONE
Strength
2%;1%
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
AT
Application
ANDA 088759
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ACETIC ACID, GLACIAL; HYDROCORTISONE
- —VOSOL HCBrand (NDA)
NDA 012770 · SAPTALIS PHARMS
- 2006HYDROCORTISONE AND ACETIC ACIDGeneric (ANDA)
ANDA 040609 · COSETTE PHARMS NC
- 1996HYDROCORTISONE AND ACETIC ACIDGeneric (ANDA)
ANDA 040168 · WOCKHARDT
- 1994HYDROCORTISONE AND ACETIC ACIDGeneric (ANDA)
ANDA 040097 · BAUSCH AND LOMB
- 1982ACETASOL HCGeneric (ANDA)
ANDA 087143 · ACTAVIS MID ATLANTIC
- —ACETIC ACID W/ HYDROCORTISONEGeneric (ANDA)
ANDA 085492 · KV PHARM
- —ORLEX HCGeneric (ANDA)
ANDA 086844 · 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.
