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FDA Orange Book · active-ingredient family

Betamethasone sodium phosphate

Betamethasone sodium phosphate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CELESTONE · NDA 017561

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CELESTONERLDSCHERINGNDA 017561Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
BETAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 085738Approved Prior to Jan 1, 1982

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.

Betamethasone sodium phosphate — frequently asked questions

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

Agent CTA Background

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