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Last Updated: March 28, 2024

Betamethasone sodium phosphate - Generic Drug Details


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What are the generic drug sources for betamethasone sodium phosphate and what is the scope of freedom to operate?

Betamethasone sodium phosphate is the generic ingredient in two branded drugs marketed by Watson Labs and Schering, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for betamethasone sodium phosphate.

Recent Clinical Trials for betamethasone sodium phosphate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Affiliated Hospital of Nantong UniversityN/A
University of Southern CaliforniaPhase 4
Surface Pharmaceuticals, Inc.Phase 2

See all betamethasone sodium phosphate clinical trials

US Patents and Regulatory Information for betamethasone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering CELESTONE betamethasone sodium phosphate INJECTABLE;INJECTION 017561-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs BETAMETHASONE SODIUM PHOSPHATE betamethasone sodium phosphate INJECTABLE;INJECTION 085738-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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