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Orange Book product · Generic (ANDA)

CYCLOMYDRIL

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Generic (ANDA)ANDA 084300RX ALCON LABS INC

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

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Strength

0.2%;1%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 084300

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.