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

DimensionValueRecordsShare
Shortage statusCurrent2100%
Therapeutic categoryPsychiatry2100%

Current shortages (2)

Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.

ShortageStatusSinceUpdatedLines filedPresentationsStrengths
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.

ShortagePresentationStrengthPackage NDCStatusAvailability (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 / drugRecord typeLinesDate
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.

YearRecallsShortage observationsApprovalsTotal
20260202
20230101
20220101

Related manufacturers

Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.

FirmRelationRecordsRecallsShortagesLatest
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.

ShortageStatusRelationSinceUpdatedPresentationsFirms
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.

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.