FdaApprovalPulse: Drug labeling or REMS supplement
1,174 fdaApprovalPulse: Drug labeling or REMS supplement are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-08-03 to 2026-10-28; the most frequent is APOTEX with 22. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
1,174 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (the 500 newest are listed here), dated 2026-08-03 to 2026-10-28. Most frequent: APOTEX (22). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
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- APOTEX (22)
- HIKMA (18)
- SPECGX LLC (18)
- ACTAVIS LABS FL INC (12)
- SANDOZ (12)
How do I get new fdaApprovalPulse: Drug labeling or REMS supplement by email?
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What are the top fdaApprovalPulse: Drug labeling or REMS supplement right now?
| Record | Product | Approval | Decided |
|---|---|---|---|
| NOVARTIS | PIQRAY | Drug labeling or REMS supplement | 2026-10-28 |
| ACTELION | TRACLEER | Drug labeling or REMS supplement | 2026-10-27 |
| NATCO PHARMA LTD | BOSENTAN | Drug labeling or REMS supplement | 2026-10-27 |
| NATCO PHARMA LTD | CHLOROQUINE PHOSPHATE | Drug labeling or REMS supplement | 2026-10-27 |
| AMNEAL PHARMS CO | BOSENTAN | Drug labeling or REMS supplement | 2026-10-27 |
| L PERRIGO CO | FEXOFENADINE HYDROCHLORIDE | Drug labeling or REMS supplement | 2026-10-27 |
| NATCO PHARMA LTD | BOSENTAN | Drug labeling or REMS supplement | 2026-10-27 |
| ACTELION | TRACLEER | Drug labeling or REMS supplement | 2026-10-27 |
| WATSON LABS INC | BOSENTAN | Drug labeling or REMS supplement | 2026-10-27 |
| MEITHEAL | VORICONAZOLE | Drug labeling or REMS supplement | 2026-10-26 |
| NOVAST LABS | DROSPIRENONE AND ESTRADIOL | Drug labeling or REMS supplement | 2026-10-26 |
| DEXCEL | TOFACITINIB CITRATE | Drug labeling or REMS supplement | 2026-10-26 |
| DEXCEL | TOFACITINIB CITRATE | Drug labeling or REMS supplement | 2026-10-26 |
| DEXCEL | TOFACITINIB CITRATE | Drug labeling or REMS supplement | 2026-10-26 |
| ALEMBIC | CARBAMAZEPINE | Drug labeling or REMS supplement | 2026-10-26 |
| ASTRAZENECA | 🔒 Unlock all 500 records → | ||
| ABBVIE INC | 🔒 Unlock all 500 records → | ||
| NEUROCRINE | 🔒 Unlock all 500 records → | ||
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Which related categories and locations should I check?
Browse by approval type
PMA supplement (device change) (367) Generic drug approval (ANDA) (194) Drug efficacy supplement (new indication or use) (76) Drug manufacturing (CMC) supplement (55) New drug application (NDA) (40) PMA original approval (new class III device) (24) Biologic license (BLA) (17) Other drug supplement (12)
Browse by sponsor state (devices)
California (110) Minnesota (61) Massachusetts (37) Oregon (20) Arizona (18) Texas (18) Illinois (9) Maryland (9) Tennessee (8) Pennsylvania (7) Florida (6) Washington (6) Missouri (5) Wisconsin (5) Colorado (4) Connecticut (4) Georgia (4) Indiana (4) New Jersey (4) New York (4) North Carolina (3) Ohio (3)
Frequently asked questions
How many fdaApprovalPulse: Drug labeling or REMS supplement are listed?
1,174 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (the 500 newest are shown on this page), last refreshed automatically. The most recent is dated 2026-10-28.
Can I get alerts for Drug labeling or REMS supplement?
Yes. FdaApprovalPulse can email you new records matching this filter; plans are listed on the FdaApprovalPulse page.
Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Informational only. RSS feed of new records