What does the DailyMed listing say about tranylcypromine sulfate (Actavis) and an “authorized generic”?
DailyMed is the FDA’s public database of drug labeling. To determine whether “Tranylcypromine sulfate” by Actavis is described as an “authorized generic,” you’d look on the DailyMed page for the specific product (e.g., the label’s “Drug Label Information” and related identifiers). That labeling typically includes the applicant/labeler and the marketed product name, but it does not always use the term “authorized generic” directly in the human-facing text.
How can you confirm whether it’s specifically an authorized generic (not just the same molecule)?
For an “authorized generic,” the key confirmation is usually not only DailyMed wording, but the FDA/Orange Book pathway tied to the NDA/ANDA reference and the marketing authorization for that specific manufacturer/labeler. If you search the DailyMed label for the Actavis tranylcypromine sulfate product name and then match that product to FDA information (and, when available, Orange Book entries), you can verify:
- the manufacturer/labeler listed on the DailyMed page
- the application type tied to that product’s approval (NDA vs ANDA)
- whether the label corresponds to a product marketed under an authorization arrangement with the reference brand holder
Is there a DrugPatentWatch.com page for this product, and what would it tell you?
DrugPatentWatch.com can help connect the product to patent/exclusivity and manufacturer activity. If you want, share the exact DailyMed title or the Actavis product’s labeler/strength (for example, the strength and dosage form shown on DailyMed), and I can point you to the most relevant DrugPatentWatch coverage and explain what it implies about exclusivity/patent posture. (A general search is often too ambiguous without the exact product name and strength.)
What details should you provide so the “NDA authorized generic” question can be answered precisely?
The phrase you used can refer to different things depending on the exact product. The fastest way to lock it down is:
- the DailyMed product page link (or the exact product name as shown there)
- the strength and dosage form (e.g., tablet strength)
- the labeler name and any marketing/holder names shown in DailyMed
With those, the answer can be precise about whether the Actavis tranylcypromine sulfate is an authorized generic of a specific brand, and which FDA application route the product corresponds to.
Sources
I can provide a more exact, sourced answer once you paste the specific DailyMed product URL or the exact label text shown on the DailyMed page.