ZYDUS PHARMS USA INC: labeling supplement approved for GALANTAMINE HYDROBROMIDE
ZYDUS PHARMS USA INC: labeling supplement approved for GALANTAMINE HYDROBROMIDE. Dated 13 days ago, it is in the active follow-up window. Score 65/100. 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 | ZYDUS PHARMS USA INC |
| Product | GALANTAMINE HYDROBROMIDE |
| Generic / ingredient | GALANTAMINE HYDROBROMIDE |
| Approval | Drug labeling or REMS supplement |
| Application | ANDA078898 supplement 10 |
| Decided | 2026-10-22 |
| Panel / class | TABLET, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch ZYDUS PHARMS USA 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.
Unlock ZYDUS PHARMS USA + 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: 2026-10-22
- 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.
65 / 100 Score
- Decided in the last 30 days.
- New labeling to print and distribute.
What is the FdaApprovalPulse record for ZYDUS PHARMS USA INC?
The FDA approved GALANTAMINE HYDROBROMIDE (ANDA078898 supplement 10) for ZYDUS PHARMS USA INC on 2026-10-22: drug labeling or REMS supplement.
How does ZYDUS PHARMS USA INC compare to other FdaApprovalPulse records?
It is fresh: dated 13 days ago, inside the window where early outreach matters most.
ZYDUS PHARMS USA INC vs. top 3 peers
Related records
FdaApprovalPulse: Drug labeling or REMS supplement
How to monitor ZYDUS PHARMS USA INC and peer drug labeling or rems supplement records
Get new FdaApprovalPulse records like ZYDUS PHARMS USA 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.