Register entry
Bausch Health US, LLC
- Registered sites
- 1
- Drug products
- 93
- Live patents
- 38
- Countries
- 1
- Base
- Canada
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Bausch Health Companies Inc. | SteinbachCanada | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806613 |
Exclusivity
Patents
38Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ARAZLO | TAZAROTENE | Jun 2036 |
| ARAZLO | TAZAROTENE | May 2038 |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | Jun 2029 |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | Aug 2029 |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | Jul 2040 |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | Dec 2040 |
| LUZU | LULICONAZOLE | Sept 2033 |
| LUZU | LULICONAZOLE | Apr 2034 |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | Mar 2027 |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | Apr 2027 |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | Nov 2031 |
| ZYCLARA | IMIQUIMOD | Aug 2029 |
| ZYCLARA | IMIQUIMOD | Dec 2029 |
| ZYCLARA | IMIQUIMOD | Apr 2030 |
Catalogue
Marketed products
93Showing 93 of 93.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ANCOBON | Flucytosine | CAPSULE | NDA |
| ANCOBON | Flucytosine | CAPSULE | NDA |
| Acanya | Clindamycin Phosphate and Benzoyl Peroxide | GEL | NDA |
| Altreno | tretinoin | LOTION | NDA |
| Aplenzin | bupropion hydrobromide | TABLET, EXTENDED RELEASE | NDA |
| Aplenzin | bupropion hydrobromide | TABLET, EXTENDED RELEASE | NDA |
| Aplenzin | bupropion hydrobromide | TABLET, EXTENDED RELEASE | NDA |
| Arazlo | tazarotene | LOTION | NDA |
| Ativan | lorazepam | TABLET | NDA |
| Ativan | lorazepam | TABLET | NDA |
| Ativan | lorazepam | TABLET | NDA |
| Atralin | Tretinoin | GEL | NDA |
| Benzamycin | erythromycin and benzoyl peroxide | KIT | NDA |
| Bryhali | halobetasol propionate | LOTION | NDA |
| Cabtreo | clindamycin phosphate/benzoyl peroxide/adapalene | GEL | NDA |
| Caladryl | Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride | LOTION | OTC MONOGRAPH DRUG |
| Caladryl Clear | PRAMOXINE HYDROCHLORIDE and ZINC ACETATE | LOTION | OTC MONOGRAPH DRUG |
| Cardizem | Diltiazem Hydrochloride | TABLET, COATED | NDA |
| Cardizem | Diltiazem Hydrochloride | TABLET, COATED | NDA |
| Cardizem | Diltiazem Hydrochloride | TABLET, COATED | NDA |
| Cardizem CD | diltiazem hydrochloride | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| Cardizem CD | diltiazem hydrochloride | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| Cardizem CD | diltiazem hydrochloride | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| Cardizem CD | diltiazem hydrochloride | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| Cardizem CD | diltiazem hydrochloride | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cardizem LA | Diltiazem Hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Cesamet | Nabilone | CAPSULE | NDA |
| Clindagel | CLINDAMYCIN | GEL | NDA |
| Cuprimine | penicillamine | CAPSULE | NDA |
| Demser | metyrosine | CAPSULE | NDA |
| Duobrii | halobetasol propionate and tazarotene | LOTION | NDA |
| EDECRIN | ethacrynic acid | TABLET | NDA |
| Efudex | Fluorouracil | CREAM | NDA |
| JUBLIA | efinaconazole | SOLUTION | NDA |
| Klaron | sulfacetamide sodium | LOTION | NDA |
| Librax | Chlordiazepoxide Hydrochloride and Clidinium Bromide | CAPSULE | NDA |
| Lodosyn | carbidopa | TABLET | NDA |
| Luzu | LULICONAZOLE | CREAM | NDA |
| Mestinon | pyridostigmine bromide | TABLET | NDA |
| Mestinon | pyridostigmine bromide | SOLUTION | NDA |
| Mestinon | pyridostigmine bromide | TABLET, EXTENDED RELEASE | NDA |
| Mysoline | Primidone | TABLET | NDA |
| Mysoline | Primidone | TABLET | NDA |
| Noritate | metronidazole | CREAM | NDA |
| ONEXTON | Clindamycin Phosphate and Benzoyl Peroxide | GEL | NDA |
| Pepcid | famotidine | TABLET, FILM COATED | ANDA |
| Pepcid | famotidine | TABLET, FILM COATED | ANDA |
| Renova | Tretinoin | CREAM | NDA |
| Retin-A | Tretinoin | CREAM | NDA |
| Retin-A | Tretinoin | CREAM | NDA |
| Retin-A | Tretinoin | CREAM | NDA |
| Retin-A | Tretinoin | GEL | NDA |
| Retin-A | Tretinoin | GEL | NDA |
| Retin-A MICRO | Tretinoin | GEL | NDA |
| Retin-A MICRO | Tretinoin | GEL | NDA |
| Retin-A MICRO | Tretinoin | GEL | NDA |
| Retin-A MICRO | Tretinoin | GEL | NDA |
| Siliq | Brodalumab | INJECTION | BLA |
| Syprine | trientine hydrochloride | CAPSULE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| Targretin | bexarotene | GEL | NDA |
| Targretin | bexarotene | CAPSULE, LIQUID FILLED | NDA |
| Tasmar | Tolcapone | TABLET, FILM COATED | NDA |
| Tetracaine Hydrochloride | Tetracaine Hydrochloride | SOLUTION/ DROPS | NDA |
| TheraSeal | Dimethicone | CREAM | OTC MONOGRAPH DRUG |
| Vanos | fluocinonide | CREAM | NDA |
| Vaseretic | enalapril maleate and hydrochlorothiazide | TABLET | NDA |
| Vasotec | Enalapril Maleate | TABLET | NDA |
| Vasotec | Enalapril Maleate | TABLET | NDA |
| Vasotec | Enalapril Maleate | TABLET | NDA |
| Vasotec | Enalapril Maleate | TABLET | NDA |
| Visudyne | verteporfin for injection | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| WELLBUTRIN XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| WELLBUTRIN XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE | NDA |
| Xerese | Acyclovir and Hydrocortisone | CREAM | NDA |
| ZELAPAR | SELEGILINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING | NDA |
| ZIANA | clindamycin phosphate and tretinoin | GEL | NDA |
| Zovirax | acyclovir | OINTMENT | NDA |
| Zovirax | acyclovir | CREAM | NDA |
| Zyclara | imiquimod | CREAM | NDA |
| Zyclara | imiquimod | CREAM | NDA |
| Zyclara | imiquimod | CREAM | NDA |
| - | fluocinolone acetonide implant | IMPLANT | BULK INGREDIENT |
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.