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Last Updated: March 29, 2024

Dexbrompheniramine maleate - Generic Drug Details


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What are the generic sources for dexbrompheniramine maleate and what is the scope of freedom to operate?

Dexbrompheniramine maleate is the generic ingredient in seven branded drugs marketed by Schering, Copley Pharm, Avanthi Inc, Sandoz, Schering Plough, and Pioneer Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for dexbrompheniramine maleate.

Summary for dexbrompheniramine maleate
US Patents:0
Tradenames:7
Applicants:6
NDAs:7
Drug Master File Entries: 6
Raw Ingredient (Bulk) Api Vendors: 36
DailyMed Link:dexbrompheniramine maleate at DailyMed

US Patents and Regulatory Information for dexbrompheniramine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering DISOPHROL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET;ORAL 012394-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Schering DISOMER dexbrompheniramine maleate SYRUP;ORAL 011814-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pioneer Pharms RESPORAL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 089139-001 Jun 16, 1988 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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