Amneal Pharms: FDA regulatory profile

Amneal Pharms appears in 2 indexed U.S. FDA records: 2 approval records, naming 2 distinct products. Latest dated event: a approval record dated 2026-08-14. Observations run 2026-08-11 to 2026-08-14 — 3 days, 2 dated records across 1 calendar year, busiest 2026 with 2. Approvals: 2 records, 2 carrying an approval date. 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. Approval records include Buprenorphine Hydrochloride And Naloxone Hydrochloride (2026-08-14) and Spironolactone (2026-08-11). 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; no recall or shortage record (approvals only)). 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 0
Source rows filed 0
Approval records 2
Current shortages 0
Resolved shortages 0
Discontinued shortages 0
Unique products 2
Recall classifications 0
Recall statuses 0
First observed 2026-08-11
Latest observed 2026-08-14
Latest event type approval
Dated observations 2
Years covered 1
Span (days) 3
Busiest year 2026 (2 records)
Related firms / shortages 0 / 0

Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.

Approval records (2)

ProductGenericApplicationMarketing statusApproved
Buprenorphine Hydrochloride And Naloxone Hydrochloride Buprenorphine Hydrochloride ANDA203136 Prescription 2026-08-14
Spironolactone Spironolactone ANDA091426 Prescription 2026-08-11

Approval records are indexed on the drug approvals hub; they do not have individual record pages on this site.

Products and drugs named (2)

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

Product / drugRecord typeLinesDate
Buprenorphine Hydrochloride And Naloxone Hydrochloride approval
Spironolactone approval

Source limitations

Built from the 2 ingested FDA records for this firm (0 recall, 0 shortage, 2 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.