Orange Book product · Generic (ANDA)
ORLEX HC
ACETIC ACID, GLACIAL; HYDROCORTISONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ACETIC ACID, GLACIAL; HYDROCORTISONE
Strength
2%;1%
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
Not listed
Application
ANDA 086844
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 1985HYDROCORTISONE AND ACETIC ACIDGeneric (ANDA)
ANDA 088759 · TARO
- 1982ACETASOL HCGeneric (ANDA)
ANDA 087143 · ACTAVIS MID ATLANTIC
- —ACETIC ACID W/ HYDROCORTISONEGeneric (ANDA)
ANDA 085492 · KV PHARM
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.
