Approved, investigational, discontinued, compounded: what each status means

Every entry on this site opens with a status. The word does a lot of work, and the four words we use mean specific, checkable things.

Approved

An FDA approval is a decision on one application, by one sponsor, for one product, for the indications in its label. It is recorded in Drugs@FDA with an application number (NDA for a drug, BLA for a biologic), an approval date, and the letter that granted it. Everything else about the product flows from that record:

• The label (prescribing information) is the FDA-agreed statement of what the product is for, how it is dosed, what was seen in trials, and what to warn about. It is the source for the dosing tables and adverse-reaction tables on this site.
• Supplements add to the approval: a new indication (Wegovy for MASH, 15 August 2025), a new dose (Wegovy 7.2 mg, 19 March 2026), a new population (Mounjaro for children 10 and older, 19 December 2025). Each has its own date and often its own letter, which is why the approval tables on the agent pages have many rows.
• Accelerated approval is still approval, with a condition. The Wegovy MASH letter grants approval based on improvement in liver histology and requires a confirmatory trial; the label says continued approval may depend on it.

Approved does not mean approved for everything. Trulicity is approved for diabetes and cardiovascular risk, not for weight; Foundayo is approved for weight, not for diabetes; Zepbound is approved for sleep apnea, Mounjaro is not. The agent pages list indications per product for that reason.

Discontinued

Drugs@FDA carries a marketing status for each product: prescription, over-the-counter, discontinued, or (for a generic waiting on patents) tentative approval. Discontinued means the sponsor is no longer marketing the product. The approval remains. On 4 September 2026 that is the state of Byetta, Bydureon and Bydureon BCise (exenatide) and Tanzeum (albiglutide). It is different from a safety withdrawal, in which FDA requests or requires removal; nothing in the public record for either agent shows that, and albiglutide's cardiovascular trial published a benefit after the product had gone.

Lixisenatide illustrates the opposite trap. Adlyxin is widely assumed to be gone, but Drugs@FDA lists it as a prescription product with a label revised in March 2026. We report the record, not the assumption.

Investigational

An investigational drug is being studied under an Investigational New Drug application and has no marketing approval. Four entries are in that state: retatrutide, survodutide, CagriSema and mazdutide. All four have phase 3 results in print. None has an application in Drugs@FDA on the date checked.

What that means in practice:

• There is no label, so there is no dosing schedule to cite, no adverse-reaction table, no boxed warning. The entries describe what the trial abstracts report and stop there.
• Published results are the sponsor's trial results as reviewed by a journal, not as reviewed by FDA. The two reviews ask different questions and sometimes reach different numbers; compare ATTAIN-1's abstract with the Foundayo label's Table 6 imputation notes to see the kind of difference.
• Availability is zero outside a trial. Any product sold under one of these names is unapproved and untested, and this site does not describe dosing for it.

Compounded

Compounding is the preparation of a drug by a licensed pharmacy (section 503A) or an outsourcing facility (section 503B) for a specific prescription or, for 503B, in bulk for healthcare providers. FDA's own page states the position in one line: compounded drugs are not FDA approved. They are not reviewed for safety, effectiveness or quality before they are sold, and they have no label.

For this site that has three consequences:

1. None of the dosing, trial or adverse-reaction data on any entry applies to a compounded product. The numbers describe Ozempic, Wegovy, Mounjaro, Zepbound and the others, made by their sponsors under the conditions FDA reviewed.
2. A compounded product is not interchangeable with the brand product even when the active ingredient is the same name. Concentration, excipients, salt forms and quality control differ from pharmacy to pharmacy. FDA's concerns page on unapproved GLP-1s documents dosing errors that followed from exactly those differences.
3. FormBlends, which publishes this site, dispenses compounded semaglutide and tirzepatide through licensed pharmacies. That is disclosed on every page. If you are considering it, read the FormBlends semaglutide and tirzepatide pages with this guide in mind, and use the Compounding Explained site for what a 503A pharmacy may and may not do.

How the status line is written on each entry

Approved entries say approved and list the products that are marketed. Discontinued entries say so and give the Drugs@FDA marketing status and the date of the last label. Investigational entries say investigational, state that no application appears in Drugs@FDA on the date checked, and carry a warning box at the top. No entry uses "coming soon", "pending" or "expected", because none of those is a status FDA records.