Question 1

Is there a generic for Ciprofloxacin hydrochloride; hydrocortisone?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ciprofloxacin hydrochloride; hydrocortisone, referencing the brand CIPRO HC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Ciprofloxacin hydrochloride; hydrocortisone?

Accepted Answer

CIPRO HC (NDA 020805, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Ciprofloxacin hydrochloride; hydrocortisone have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Ciprofloxacin hydrochloride; hydrocortisone. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Ciprofloxacin hydrochloride; hydrocortisone are approved?

Accepted Answer

Ciprofloxacin hydrochloride; hydrocortisone is approved in the following dosage form: suspension/drops.

Ciprofloxacin hydrochloride; hydrocortisone

Brand (NDA) products · suspension/drops

Generic (ANDA) products (1)

Marketing exclusivity (1)

Listed patents

Ciprofloxacin hydrochloride; hydrocortisone — frequently asked questions

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