Mylan Specialty, A Viatris Company: FDA regulatory profile

Mylan Specialty, A Viatris Company 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 2023-11-03 to 2026-08-20 — 1021 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, 2 package NDCs and 1 brand name. 0 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 (1), 2023 (1). Shortage entries include Cromolyn Sodium Concentrate (Current, since 2023-11-03, 1 lines). FDA therapeutic categories covered: Pulmonary/Allergy. Strengths reported: 20 mg/1 mL. 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 2023-11-03
Latest observed 2026-08-20
Latest event type shortage
Dated observations 2
Years covered 2
Span (days) 1021
Busiest year 2026 (1 records)
Lines per entry (mean) 1
Therapeutic categories 1
Distinct strengths 1
Package NDCs 2
Brand names 1
Related firms / shortages 0 / 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 statusCurrent1100%
Therapeutic categoryPulmonary/Allergy1100%

Current shortages (1)

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

ShortageStatusSinceUpdatedLines filedPresentationsStrengths
Cromolyn Sodium Concentrate (Gastrocrom) Current 2023-11-03 2026-08-20 1 1 20 mg/1 mL

Package lines filed (1)

The openFDA shortage lines this firm filed, with the agency's own availability text.

ShortagePresentationStrengthPackage NDCStatusAvailability (FDA text)Updated
Cromolyn Sodium Concentrate Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) 20 mg/1 mL 0037-0678-96 Current Available 2026-08-20

Products and drugs named (1)

De-duplicated by record entity, not raw source row.

Product / drugRecord typeLinesDate
Cromolyn Sodium Concentrate shortage 1 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.

ShortageStatusRelationSinceUpdatedPresentationsFirms
Dexamethasone Sodium Phosphate Injection Current same therapeutic category 2019-02-08 2026-08-20 4 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.

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.