- [Home](/) › - [FdaApprovalPulse](/v/fdaapprovalpulse) › - [Hubs](/hub/fdaapprovalpulse) › - Drug labeling or REMS supplement # 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 2026-11-03 · [Compiled by Zalwin](/research/fdaapprovalpulse) from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) Copy citation Download the newest 500 fdaApprovalPulse: Drug labeling or REMS supplement (CSV) — $4.99 → Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdaapprovalpulse/records.csv?type=suppl_labeling) 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). **Search, filter and export FdaApprovalPulse records** [Run instant live search with these filters](/v/fdaapprovalpulse?type=suppl_labeling&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdaapprovalpulse/records.csv?type=suppl_labeling) Unlock the full CSV for these filters — $4.99 → ✓ 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 ## Get new FdaApprovalPulse records 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. [See this week's digest](/digest/fdaapprovalpulse) Records 1,174 Most frequent - 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? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdaapprovalpulse?type=suppl_labeling) [Watch this exact filter](/v/fdaapprovalpulse?type=suppl_labeling#more-ways) [See alert plans](/v/fdaapprovalpulse#pricing) ## 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 | Included in the full CSV with every column 🔒 Unlock all 500 records → | | ABBVIE INC | Included in the full CSV with every column 🔒 Unlock all 500 records → | | NEUROCRINE | Included in the full CSV with every column 🔒 Unlock all 500 records → | Browse 35 more matching record reports - [ASTRAZENECA](/report/fdaapprovalpulse/astrazeneca--dfda-nda216579-s2) - [ABBVIE INC](/report/fdaapprovalpulse/abbvie-inc--dfda-bla761262-s19) - [NEUROCRINE](/report/fdaapprovalpulse/neurocrine--dfda-nda209241-s34) - [SANDOZ INC](/report/fdaapprovalpulse/sandoz-inc--dfda-bla761362-s13) - [ALEMBIC](/report/fdaapprovalpulse/alembic--dfda-anda218535-s2) - [MEITHEAL](/report/fdaapprovalpulse/meitheal--dfda-anda204843-s4) - [MEITHEAL](/report/fdaapprovalpulse/meitheal--dfda-anda204843-s8) - [MEITHEAL](/report/fdaapprovalpulse/meitheal--dfda-anda204843-s6) - [APOTEX](/report/fdaapprovalpulse/apotex--dfda-anda077561-s25) - [COSETTE](/report/fdaapprovalpulse/cosette--dfda-nda210557-s5) - [ZYDUS PHARMS USA INC](/report/fdaapprovalpulse/zydus-pharms-usa-inc--dfda-anda078898-s10) - [PFIZER](/report/fdaapprovalpulse/pfizer--dfda-nda021132-s49) - [PFIZER](/report/fdaapprovalpulse/pfizer--dfda-nda021130-s49) - [PFIZER](/report/fdaapprovalpulse/pfizer--dfda-nda021131-s47) - [SOMERSET THERAPS LLC](/report/fdaapprovalpulse/somerset-theraps-llc--dfda-anda206791-s9) - [CELGENE CORP](/report/fdaapprovalpulse/celgene-corp--dfda-bla761136-s17) - [SOMERSET](/report/fdaapprovalpulse/somerset--dfda-anda209132-s9) - [SUN PHARM INDS LTD](/report/fdaapprovalpulse/sun-pharm-inds-ltd--dfda-anda078464-s14) - [ZYDUS](/report/fdaapprovalpulse/zydus--dfda-anda063009-s48) - [ZYDUS](/report/fdaapprovalpulse/zydus--dfda-anda063009-s49) - [ZYDUS](/report/fdaapprovalpulse/zydus--dfda-anda063011-s43) - [ZYDUS](/report/fdaapprovalpulse/zydus--dfda-anda063011-s44) - [PH HEALTH](/report/fdaapprovalpulse/ph-health--dfda-nda204200-s23) - [HETERO LABS LTD V](/report/fdaapprovalpulse/hetero-labs-ltd-v--dfda-anda211598-s3) - [ANTIBIOTICE](/report/fdaapprovalpulse/antibiotice--dfda-anda201406-s11) - [ANTIBIOTICE](/report/fdaapprovalpulse/antibiotice--dfda-anda201406-s9) - [ACTAVIS LABS FL INC](/report/fdaapprovalpulse/actavis-labs-fl-inc--dfda-anda209253-s7) - [RISING](/report/fdaapprovalpulse/rising--dfda-anda205531-s2) - [RISING](/report/fdaapprovalpulse/rising--dfda-anda205531-s3) - [ACTAVIS LABS FL INC](/report/fdaapprovalpulse/actavis-labs-fl-inc--dfda-anda075416-s24) - [INGENUS PHARMS LLC](/report/fdaapprovalpulse/ingenus-pharms-llc--dfda-anda216404-s4) - [INGENUS PHARMS LLC](/report/fdaapprovalpulse/ingenus-pharms-llc--dfda-anda216404-s3) - [RISING](/report/fdaapprovalpulse/rising--dfda-anda213212-s1) - [SHORLA ONCOLOGY](/report/fdaapprovalpulse/shorla-oncology--dfda-nda219097-s4) - [BIOCRYST](/report/fdaapprovalpulse/biocryst--dfda-nda214094-s6) More records in this hub: [page 2](/hub/fdaapprovalpulse/type/suppl-labeling/page/2) · [page 3](/hub/fdaapprovalpulse/type/suppl-labeling/page/3) · [page 4](/hub/fdaapprovalpulse/type/suppl-labeling/page/4) [Browse all FdaApprovalPulse record reports](/hub/fdaapprovalpulse/records) ## Which related categories and locations should I check? ### Browse by approval type [PMA supplement (device change) (367)](/hub/fdaapprovalpulse/type/pma-supplement) [Generic drug approval (ANDA) (194)](/hub/fdaapprovalpulse/type/anda) [Drug efficacy supplement (new indication or use) (76)](/hub/fdaapprovalpulse/type/suppl-efficacy) [Drug manufacturing (CMC) supplement (55)](/hub/fdaapprovalpulse/type/suppl-manufacturing) [New drug application (NDA) (40)](/hub/fdaapprovalpulse/type/nda) [PMA original approval (new class III device) (24)](/hub/fdaapprovalpulse/type/pma-original) [Biologic license (BLA) (17)](/hub/fdaapprovalpulse/type/bla) [Other drug supplement (12)](/hub/fdaapprovalpulse/type/suppl-other) ### Browse by sponsor state (devices) [California (110)](/hub/fdaapprovalpulse/state/ca) [Minnesota (61)](/hub/fdaapprovalpulse/state/mn) [Massachusetts (37)](/hub/fdaapprovalpulse/state/ma) [Oregon (20)](/hub/fdaapprovalpulse/state/or) [Arizona (18)](/hub/fdaapprovalpulse/state/az) [Texas (18)](/hub/fdaapprovalpulse/state/tx) [Illinois (9)](/hub/fdaapprovalpulse/state/il) [Maryland (9)](/hub/fdaapprovalpulse/state/md) [Tennessee (8)](/hub/fdaapprovalpulse/state/tn) [Pennsylvania (7)](/hub/fdaapprovalpulse/state/pa) [Florida (6)](/hub/fdaapprovalpulse/state/fl) [Washington (6)](/hub/fdaapprovalpulse/state/wa) [Missouri (5)](/hub/fdaapprovalpulse/state/mo) [Wisconsin (5)](/hub/fdaapprovalpulse/state/wi) [Colorado (4)](/hub/fdaapprovalpulse/state/co) [Connecticut (4)](/hub/fdaapprovalpulse/state/ct) [Georgia (4)](/hub/fdaapprovalpulse/state/ga) [Indiana (4)](/hub/fdaapprovalpulse/state/in) [New Jersey (4)](/hub/fdaapprovalpulse/state/nj) [New York (4)](/hub/fdaapprovalpulse/state/ny) [North Carolina (3)](/hub/fdaapprovalpulse/state/nc) [Ohio (3)](/hub/fdaapprovalpulse/state/oh) ## 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](/feed/fdaapprovalpulse.xml) ## Often used together - [FDAPulse](/v/fdapulse) - [FdaNdcDirectoryPulse](/v/fdandcdirectorypulse) - [NycPropertyExemptionDetailPulse](/v/nycpropertyexemptiondetailpulse) - [MigrationRedirectAudit](/migrationredirectaudit) - [SchemaMarkupGeneratorKit](/schemageneratorkit) - [ShopifyStorefrontXray](/shopifystorefrontxray)