VANDA PHARMS INC: manufacturing (CMC) supplement approved for HETLIOZ
VANDA PHARMS INC: manufacturing (CMC) supplement approved for HETLIOZ. Dated 100 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | VANDA PHARMS INC |
| Product | HETLIOZ |
| Generic / ingredient | TASIMELTEON |
| Approval | Drug manufacturing (CMC) supplement |
| Application | NDA205677 supplement 13 |
| Decided | 2026-07-27 |
| Panel / class | CAPSULE, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch VANDA PHARMS INC
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock VANDA PHARMS + 500 peer records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-07-27
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records: Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Advanced Medical Solutions Limited · Lenstec, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
40 / 100 Score
- Manufacturing change: sites, suppliers or process.
What is the FdaApprovalPulse record for VANDA PHARMS INC?
The FDA approved HETLIOZ (NDA205677 supplement 13) for VANDA PHARMS INC on 2026-07-27: drug manufacturing (CMC) supplement.
How does VANDA PHARMS INC compare to other FdaApprovalPulse records?
It is 100 days old; check the official source for later updates before acting.
VANDA PHARMS INC vs. top 3 peers
| Organization | Record date |
|---|---|
| VANDA PHARMS INC | 2026-07-27 |
| BIOCON BIOLOGICS INC | 2026-10-22 |
| ALKEM LABS LTD | 2026-10-21 |
| ACTAVIS LABS FL INC | 2026-10-19 |
Related records
FdaApprovalPulse: Drug manufacturing (CMC) supplement
How to monitor VANDA PHARMS INC and peer drug manufacturing (cmc) supplement records
Get new FdaApprovalPulse records like VANDA PHARMS INC by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new approvals in your categories
FdaApprovalPulse emails new device and drug approvals matching your approval types.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.