Alvogen: FDA regulatory profile
Alvogen appears in 3 indexed U.S. FDA records: 2 drug-shortage entries (from 4 openFDA source rows) and 1 approval record, naming 3 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2022-10-12 to 2026-08-20 — 1408 days, 5 dated records across 3 calendar years, busiest 2026 with 3. Shortages: 2 current, averaging 2 package lines each across 1 FDA therapeutic category, 4 strengths, 134 package NDCs and 3 brand names. Approvals: 1 record, 1 carrying an approval date. 6 related firms and 1 adjacent shortage entry 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 (3), 2023 (1), 2022 (1). Shortage entries include Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Current, since 2022-10-12, 3 lines) and Lisdexamfetamine Dimesylate Capsule (Current, since 2023-07-14, 1 lines).
Regulatory snapshot
| Indexed records | 3 |
|---|---|
| Recall records | 0 |
| Shortage entries | 2 |
| Source rows filed | 4 |
| Approval records | 1 |
| Current shortages | 2 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 3 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2022-10-12 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 5 |
| Years covered | 3 |
| Span (days) | 1408 |
| Busiest year | 2026 (3 records) |
| Lines per entry (mean) | 2 |
| Therapeutic categories | 1 |
| Distinct strengths | 4 |
| Package NDCs | 134 |
| Brand names | 3 |
| Related firms / shortages | 6 / 1 |
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 | 2 | 100% |
| Therapeutic category | Psychiatry | 2 | 100% |
Current shortages (2)
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 |
|---|---|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Adderall, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii) | Current | 2022-10-12 | 2026-08-20 | 3 | 3 | 15mg, 20mg, 30mg |
| Lisdexamfetamine Dimesylate Capsule (Vyvanse) | Current | 2023-07-14 | 2026-08-20 | 1 | 1 | 20 mg |
Package lines filed (4)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 20mg (NDC 47781-179-01) | 20mg | 47781-179-01 | Current | Available | 2026-08-17 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 30mg (NDC 47781-180-01) | 30mg | 47781-180-01 | Current | Available | 2026-08-17 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 15mg (NDC 47781-178-01) | 15mg | 47781-178-01 | Current | Available | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 47781-563-01) | 20 mg | 47781-563-01 | Current | Available | 2026-08-17 |
Approval records (1)
| Product | Generic | Application | Marketing status | Approved |
|---|---|---|---|---|
| Buprenorphine Hydrochloride And Naloxone Hydrochloride | Buprenorphine Hydrochloride | ANDA205954 | Prescription | 2026-08-14 |
Approval records are indexed on the drug approvals hub; they do not have individual record pages on this site.
Products and drugs named (3)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetam | shortage | 3 | 2026-08-20 |
| Buprenorphine Hydrochloride And Naloxone Hydrochloride | approval | — | — |
| Lisdexamfetamine Dimesylate Capsule | shortage | 1 | 2026-08-20 |
Indexed activity by year
Counts within the ingested window across 5 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 0 | 2 | 1 | 3 |
| 2023 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 1 | 0 | 1 |
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 |
|---|---|---|---|---|---|
| Elite Laboratories, Inc. | co-reports the same shortage | 2 | 0 | 2 | 2026-08-20 |
| Epic Pharma, LLC | co-reports the same shortage | 2 | 0 | 2 | 2026-08-20 |
| Granules Pharmaceuticals Inc. | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Lannett Company Inc. | co-reports the same shortage | 6 | 3 | 3 | 2026-08-20 |
| Mylan Pharmaceuticals Inc., A Viatris Company | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Novadoz Pharmaceuticals LLC | reports a shortage of the same substance | 1 | 0 | 1 | 2026-08-17 |
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 |
|---|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate Tablet, Chewable | Current | same therapeutic category | 2023-07-14 | 2026-08-17 | 2 | 1 |
Source limitations
Built from the 3 ingested FDA records for this firm (0 recall, 2 shortage, 1 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.