Elite Laboratories, Inc.: FDA regulatory profile
Elite Laboratories, Inc. appears in 2 indexed U.S. FDA records: 2 drug-shortage entries (from 10 openFDA source rows), naming 2 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2022-10-12 to 2026-08-20 — 1408 days, 4 dated records across 3 calendar years, busiest 2026 with 2. Shortages: 2 current, averaging 5 package lines each across 1 FDA therapeutic category, 10 strengths, 134 package NDCs and 3 brand names. 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 (2), 2023 (1), 2022 (1). Shortage entries include Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Current, since 2022-10-12, 6 lines) and Lisdexamfetamine Dimesylate Capsule (Current, since 2023-07-14, 4 lines). This firm appears in 2 indexed records, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 2 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 | 2 |
|---|---|
| Recall records | 0 |
| Shortage entries | 2 |
| Source rows filed | 10 |
| Approval records | 0 |
| Current shortages | 2 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 2 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2022-10-12 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 4 |
| Years covered | 3 |
| Span (days) | 1408 |
| Busiest year | 2026 (2 records) |
| Lines per entry (mean) | 5 |
| Therapeutic categories | 1 |
| Distinct strengths | 10 |
| 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 | 6 | 6 | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg |
| Lisdexamfetamine Dimesylate Capsule (Vyvanse) | Current | 2023-07-14 | 2026-08-20 | 4 | 4 | 10 mg, 30 mg, 40 mg, 50 mg |
Package lines filed (10)
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, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 64850-500-01) | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg | 64850-500-01 | 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, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 64850-504-01) | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg | 64850-504-01 | 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, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 64850-506-01) | 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg | 64850-506-01 | 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, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 64850-502-01) | 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg | 64850-502-01 | 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, 5 mg; 5 mg; 5 mg; 5 mg (NDC 64850-505-01) | 5 mg; 5 mg; 5 mg; 5 mg | 64850-505-01 | 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, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 64850-501-01) | 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg | 64850-501-01 | Current | Available | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 64850-554-01) | 50 mg | 64850-554-01 | Current | Limited Availability | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 64850-553-01) | 40 mg | 64850-553-01 | Current | Limited Availability | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 64850-552-01) | 30 mg | 64850-552-01 | Current | Limited Availability | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 64850-550-01) | 10 mg | 64850-550-01 | Current | Limited Availability | 2026-08-17 |
Products and drugs named (2)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetam | shortage | 6 | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | shortage | 4 | 2026-08-20 |
Indexed activity by year
Counts within the ingested window across 4 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 0 | 2 | 0 | 2 |
| 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 |
|---|---|---|---|---|---|
| Alvogen | co-reports the same shortage | 3 | 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 2 ingested FDA records for this firm (0 recall, 2 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.