Marketing-authorisation holder
Granules
11 medicines in 1 country, as authorisation holder.
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Marketing-authorisation holder
11 medicines in 1 country, as authorisation holder.
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Groups are put together by Prognia from the names regulators publish and from company links; they are not an official corporate structure.
Every medicine in the registers under its name, current ones first.
11 medicines
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE250mg; 250mg; 65mg · Tablet | Paracetamol, Acetylsalicylic acid, Caffeine | United States | Marketed | 2001 |
| AMPHETAMINE SULFATE10MG | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 5MG | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet | Amfetamine | United States | Marketed | 1984 |
| BUTALBITAL AND ACETAMINOPHEN300mg; 50mg · Capsule | Paracetamol, Butalbital | United States | Marketed | 2017 |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2gm; 120mg | 600mg; 60mg · Tablet, extended release | Guaifenesin, Pseudoephedrine | United States | Marketed | 2015 |
| IBUPROFEN100mg | 200mg | 300mg | 400mg | 600mg | 800mg · Tablet | Ibuprofen | United States | Marketed | 1985 |
| PENICILLAMINE250mg · Capsule | Penicillamine | United States | Marketed | 2019 |
| SILDENAFIL CITRATE10mg base/ml · For suspension | Sildenafil | United States | Marketed | 2019 |
| VIGABATRIN500mg/packet · For solution | Vigabatrin | United States | Marketed | 2017 |
| ZONISAMIDE100mg | 25mg | 50mg · Capsule | Zonisamide | United States | Marketed | 2005 |
| AMPHETAMINE10mg | 15mg | 20mg · Tablet, extended release | Amfetamine | United States | tentative | 2026 |
| AMPHETAMINE12.5mg | 15.7mg | 18.8mg | 3.1mg | 6.3mg | 9.4mg · Tablet, orally disintegrating | Amfetamine | United States | tentative | 2025 |
Where it holds or makes medicines, with how many are current.
| Country | Medicines | Current | Past | Companies |
|---|---|---|---|---|
| United States | 11 | 9 | 2 | CompaniesAll medicines |
The active substances in most of its medicines.
How the registers spell it, normalised: legal forms, accents and capitals removed.
Compiled by Prognia from the public medicine and company registers below. Logos are not used.
Source: U.S. FDA, Drugs@FDA / openFDA. FDA does not endorse this site.
Licence: Public domain (U.S. Government work)
Report an error or request removalCorrections from the company itself are welcome.
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