Propoxyphene napsylate - Generic Drug Details
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What are the generic drug sources for propoxyphene napsylate and what is the scope of freedom to operate?
Propoxyphene napsylate
is the generic ingredient in one branded drug marketed by Aaipharma Llc and Xanodyne Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for propoxyphene napsylate.
Summary for propoxyphene napsylate
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Clinical Trials: | 1 |
Patent Applications: | 13 |
What excipients (inactive ingredients) are in propoxyphene napsylate? | propoxyphene napsylate excipients list |
DailyMed Link: | propoxyphene napsylate at DailyMed |
Recent Clinical Trials for propoxyphene napsylate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Xanodyne Pharmaceuticals | Phase 4 |
US Patents and Regulatory Information for propoxyphene napsylate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xanodyne Pharm | DARVON-N | propoxyphene napsylate | TABLET;ORAL | 016862-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aaipharma Llc | DARVON-N | propoxyphene napsylate | SUSPENSION;ORAL | 016861-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |