Merck & Co. (MSD)
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record. See the Merck & Co. (MSD) group view.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 267, 12 entities
- Drug applications: 241
- Drug recalls: 16
- 510(k) clearances: 9
- Complete response letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Merck & Co. (MSD) and its 11 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 28, 2013 | Complete response letter, NDA 204569Approved | Complete response letters |
| Dec 12, 2012 | Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, SClass II · Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the | Drug recalls |
| Dec 14, 2005 | DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406K052259 · GEH | 510(k) clearances |
| Aug 29, 2003 | DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226K031697 · GEH | 510(k) clearances |
| May 4, 1988 | MODIFIED IMIPENEM SUSCEPTIBILITY POWDERK880574 · JTT | 510(k) clearances |
| Oct 13, 1987 | INSPIREASE(R), DRUG DELIVERY SYSTEMK873793 · CCQ | 510(k) clearances |
| Dec 11, 1986 | NORFLOXACIN SUSCEPTIBILITY POWDERK864442 · JTT | 510(k) clearances |
| Aug 14, 1986 | DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPEK860473 · LDE | 510(k) clearances |
| Mar 6, 1986 | IMIPENEM SUSCEPTIBILITY POWDERK855071 · JTT | 510(k) clearances |
| Aug 16, 1983 | INSPIREASEK832037 · CCQ | 510(k) clearances |
Subsidiaries and Divisions
11 firms in the Merck & Co. (MSD) group, most records first- Schering Corporation100 records
- Merck Sharp & Dohme26 records
- MSD21 records
- Cubist Pharmaceuticals11 records
- Schering-Plough11 records
- Merck, Sharp & Dohme10 records
- Msd Merck Co5 records
- Key Pharmaceuticals, Inc.4 records
- Schering-Plough Healthcare Products2 records
- Merck Sharp & Dohme, Wilson Facility1 record
- Schering-Plough Products1 record
Canada and Imports
Across the Merck & Co. (MSD) group, matched by company name- FDA import refusals since 2024
- 58 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- merck.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built