Assyro AI

FDA Orange Book · active-ingredient family

Ritodrine hydrochloride

Ritodrine hydrochloride is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:YUTOPAR · NDA 018580

2

Brand (NDA)

5

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
YUTOPAR×2ASTRAZENECANDA 018580—Approved Prior to Jan 1, 1982
YUTOPARASTRAZENECANDA 018555—Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
RITODRINE HYDROCHLORIDEHOSPIRAANDA 071618—Feb 28, 1991
RITODRINE HYDROCHLORIDEHOSPIRAANDA 071619—Feb 28, 1991
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRAANDA 071438—Jan 22, 1991
RITODRINE HYDROCHLORIDEABRAXIS PHARMANDA 071188—Jul 23, 1987
RITODRINE HYDROCHLORIDEABRAXIS PHARMANDA 071189—Jul 23, 1987

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.

Ritodrine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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