Orange Book product · Generic (ANDA)
CYCLOPENTOLATE HYDROCHLORIDE
CYCLOPENTOLATE HYDROCHLORIDE
At a glance
Dec 09, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 2015
10 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOPENTOLATE HYDROCHLORIDE
Strength
0.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 205937
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CYCLOPENTOLATE HYDROCHLORIDE
- 1997AKPENTOLATEGeneric (ANDA)
ANDA 040164 · RISING
- 1997AKPENTOLATEGeneric (ANDA)
ANDA 040165 · RISING
- 1994PENTOLAIRGeneric (ANDA)
ANDA 040075 · BAUSCH AND LOMB INC
- 1991CYCLOPENTOLATE HYDROCHLORIDEGeneric (ANDA)
ANDA 089162 · ALCON PHARMS LTD
- 1987PENTOLAIRGeneric (ANDA)
ANDA 088643 · PHARMAFAIR
- 1983PENTOLAIRGeneric (ANDA)
ANDA 088150 · PHARMAFAIR
- —AK-PENTOLATEGeneric (ANDA)
ANDA 085555 · EPIC PHARMA LLC
- —CYCLOGYLGeneric (ANDA)
ANDA 084109 · ALCON LABS INC
- —CYCLOGYLGeneric (ANDA)
ANDA 084110 · ALCON LABS INC
- —CYCLOGYLGeneric (ANDA)
ANDA 084108 · ALCON LABS INC
- —CYCLOPENTOLATE HYDROCHLORIDEGeneric (ANDA)
ANDA 084150 · SOLA BARNES HIND
- —CYCLOPENTOLATE HYDROCHLORIDEGeneric (ANDA)
ANDA 084863 · SOLA BARNES HIND
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.
