Register entry
Burel Pharmaceuticals, LLC
- Registered sites
- 0
- Drug products
- 30
- Live patents
- 0
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Catalogue
Marketed products
30Showing 30 of 30.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | OINTMENT, AUGMENTED | ANDA |
| BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | TABLET | ANDA |
| BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | TABLET | ANDA |
| Benzoyl Peroxide | Benzoyl Peroxide | LIQUID | OTC MONOGRAPH DRUG |
| Benzoyl Peroxide | Benzoyl Peroxide | LIQUID | OTC MONOGRAPH DRUG |
| Carglumic acid | Carglumic acid | TABLET, FOR SUSPENSION | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Finasteride | Finasteride | TABLET, FILM COATED | ANDA |
| KETOCONAZOLE | ketoconazole | TABLET | ANDA |
| Leflunomide | leflunomide | TABLET, FILM COATED | ANDA |
| Leflunomide | leflunomide | TABLET, FILM COATED | ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | SOLUTION | ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | SOLUTION | ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | SOLUTION | ANDA |
| MiloPhene | Clomiphene Citrate | TABLET | ANDA |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE | ANDA |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE | ANDA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | CAPSULE | ANDA |
| Pantoprazole Sodium | Pantoprazole Sodium | TABLET, DELAYED RELEASE | ANDA |
| Sodium Fluoride 1.1% | Sodium Fluoride | GEL, DENTIFRICE | UNAPPROVED DRUG OTHER |
| Sodium Polystyrene Sulfonate | sodium polystyrene sulfonate | SUSPENSION | ANDA |
| tadalafil | Tadalafil | TABLET, FILM COATED | ANDA |
| tadalafil | Tadalafil | TABLET, FILM COATED | ANDA |
| tadalafil | Tadalafil | TABLET, FILM COATED | ANDA |
| tadalafil | Tadalafil | TABLET, FILM COATED | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.