Pseudoephedrine sulfate - Generic Drug Details
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What are the generic drug sources for pseudoephedrine sulfate and what is the scope of freedom to operate?
Pseudoephedrine sulfate
is the generic ingredient in one branded drug marketed by Schering Plough and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for pseudoephedrine sulfate.
Summary for pseudoephedrine sulfate
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 8 |
Patent Applications: | 1,200 |
Formulation / Manufacturing: | see details |
DailyMed Link: | pseudoephedrine sulfate at DailyMed |
Recent Clinical Trials for pseudoephedrine sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer | Phase 1 |
Bayer | Phase 4 |
Magna Pharmaceuticals, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for pseudoephedrine sulfate
US Patents and Regulatory Information for pseudoephedrine sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering Plough | AFRINOL | pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 018191-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |