FdaApprovalPulse / report
GLAND: manufacturing (CMC) supplement approved for LEUCOVORIN CALCIUM
GLAND: manufacturing (CMC) supplement approved for LEUCOVORIN CALCIUM. Dated 21 days ago, it is in the active follow-up window. Score 70/100. As of 2026-11-03, 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 | GLAND |
| Product | LEUCOVORIN CALCIUM |
| Generic / ingredient | LEUCOVORIN CALCIUM |
| Approval | Drug manufacturing (CMC) supplement |
| Application | ANDA218200 supplement 1 |
| Decided | 2026-10-14 |
| Panel / class | INJECTABLE, INJECTION |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-14
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Tue, 03 Nov 2026 05:14:00 GMT
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70 / 100 Score
- Decided in the last 30 days.
- Manufacturing change: sites, suppliers or process.
What is the FdaApprovalPulse record for GLAND?
The FDA approved LEUCOVORIN CALCIUM (ANDA218200 supplement 1) for GLAND on 2026-10-14: drug manufacturing (CMC) supplement.
How does GLAND compare to other FdaApprovalPulse records?
It is 21 days old, still within a typical 45-day follow-up window. Its Score of 70/100 puts it among the stronger signals in this feed.
GLAND vs. top 3 peers
| Organization | Record date |
|---|---|
| GLAND | 2026-10-14 |
| 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
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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.