Azurity Pharmaceuticals, Inc: FDA regulatory profile
Azurity Pharmaceuticals, Inc appears in 1 indexed U.S. FDA record: 1 drug-shortage entry (from 1 openFDA source row), naming 1 distinct product. Latest dated event: a shortage record dated 2026-08-20. Observations run 2020-04-10 to 2026-08-20 — 2323 days, 2 dated records across 2 calendar years, busiest 2026 with 1. Shortages: 1 current, averaging 1 package lines each across 1 FDA therapeutic category, 1 strength, 23 package NDCs and 2 brand names. 5 related firms and 4 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. By year: 2026 (1), 2020 (1). Shortage entries include Dexmedetomidine Hydrochloride Injection (Current, since 2020-04-10, 1 lines). FDA therapeutic categories covered: Anesthesia. Strengths reported: 400 mcg/100 mL (4 ug/1 mL). Related firms include Accord Healthcare, Inc., Baxter Healthcare, HQ Specialty Pharma and Mylan Institutional, A Viatris Company. This firm appears in 1 indexed record, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 1 indexed record). The page is published so the record remains reachable and verifiable, and it links on to the underlying FDA records, but it is marked noindex and left out of the sitemap: a single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. Should further records reference this firm in a later ingestion, the page becomes a full profile automatically.
Regulatory snapshot
| Indexed records | 1 |
|---|---|
| Recall records | 0 |
| Shortage entries | 1 |
| Source rows filed | 1 |
| Approval records | 0 |
| Current shortages | 1 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 1 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2020-04-10 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 2 |
| Years covered | 2 |
| Span (days) | 2323 |
| Busiest year | 2026 (1 records) |
| Lines per entry (mean) | 1 |
| Therapeutic categories | 1 |
| Distinct strengths | 1 |
| Package NDCs | 23 |
| Brand names | 2 |
| Related firms / shortages | 5 / 4 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Shortage status | Current | 1 | 100% |
| Therapeutic category | Anesthesia | 1 | 100% |
Current shortages (1)
Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.
| Shortage | Status | Since | Updated | Lines filed | Presentations | Strengths |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection (Dexmedetomidine IN Dextrose, Precedex) | Current | 2020-04-10 | 2026-08-20 | 1 | 1 | 400 mcg/100 mL (4 ug/1 mL) |
Package lines filed (1)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | 400 mcg/100 mL (4 ug/1 mL) | 72572-128-08 | Current | Available | 2026-08-17 |
Products and drugs named (1)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection | shortage | 1 | 2026-08-20 |
Related manufacturers
Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.
| Firm | Relation | Records | Recalls | Shortages | Latest |
|---|---|---|---|---|---|
| Accord Healthcare, Inc. | co-reports the same shortage | 7 | 1 | 6 | 2026-08-20 |
| Baxter Healthcare | co-reports the same shortage | 14 | 0 | 14 | 2026-08-20 |
| HQ Specialty Pharma | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Mylan Institutional, A Viatris Company | co-reports the same shortage | 6 | 0 | 6 | 2026-08-20 |
| Par Health Usa, LLC | co-reports the same shortage | 3 | 1 | 2 | 2026-08-20 |
Related shortages in this firm's areas
Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.
| Shortage | Status | Relation | Since | Updated | Presentations | Firms |
|---|---|---|---|---|---|---|
| Bupivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-02-20 | 2026-08-18 | 1 | 1 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
| Ropivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-03-27 | 2026-08-18 | 6 | 1 |
Source limitations
Built from the 1 ingested FDA record for this firm (0 recall, 1 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.