Register entry
- Registered sites
- 1
- Active NDC listings
- 92
- Labeller names
- 3
- Live patents
- 38
- Exclusivities
- 1
- Countries
- 1
- Base
- Canada
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Bausch Health Companies Inc.Registrant: Bausch Health US, LLC | 100 Life Sciences Pkwy, Steinbach, Manitoba R5G 1Z7, Canada (CAN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806613253292734 |
Catalogue
Drug listings by form and route
9292 active NDC listings: 88 human prescription drug, 3 human otc drug, 1 bulk ingredient. By marketing category: NDA 85, OTC MONOGRAPH DRUG 3, ANDA 2, BLA 1, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| cream | 13 |
| gel | 13 |
| tablet | 13 |
| tablet, extended release | 12 |
| capsule | 7 |
| lotion | 7 |
| capsule, extended release | 6 |
| capsule, coated, extended release | 5 |
| tablet, coated | 3 |
| tablet, film coated | 3 |
| solution | 2 |
| capsule, liquid filled | 1 |
| implant | 1 |
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| oral | 52 |
| topical | 35 |
| intravenous | 1 |
| ophthalmic | 1 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| bausch health us, llc | 50 |
| bausch health us llc | 41 |
| bausch health ireland limited | 1 |
Exclusivity
Patents and exclusivities
38| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7919483 | SOLODYNminocycline hydrochloride | use | Mar 2027 |
| 7541347 | SOLODYNminocycline hydrochloride | use | Apr 2027 |
| 7544373 | SOLODYNminocycline hydrochloride | product | Apr 2027 |
| 10220049 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jun 2029 |
| 10624918 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | use | Jun 2029 |
| 9561208 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jun 2029 |
| 8288434 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Aug 2029 |
| 10238645 | ZYCLARAimiquimod | use | Aug 2029 |
| 8598196 | ZYCLARAimiquimod | use | Aug 2029 |
| 10238644 | ZYCLARAimiquimod | use | Dec 2029 |
| 11318130 | ZYCLARAimiquimod | use | Dec 2029 |
| 8222270 | ZYCLARAimiquimod | use | Dec 2029 |
| 8236816 | ZYCLARAimiquimod | use | Dec 2029 |
| 8299109 | ZYCLARAimiquimod | use | Dec 2029 |
| 10918635 | ZYCLARAimiquimod | use | Apr 2030 |
| 11202752 | ZYCLARAimiquimod | use | Apr 2030 |
| 11850245 | ZYCLARAimiquimod | use | Apr 2030 |
| 9192615 | SOLODYNminocycline hydrochloride | product | Nov 2031 |
| 9012484 | LUZUluliconazole | substance, product | Sept 2033 |
| 9199977 | LUZUluliconazole | substance, product | Sept 2033 |
| 9453006 | LUZUluliconazole | substance | Sept 2033 |
| 8980931 | LUZUluliconazole | product | Apr 2034 |
| 11679116 | ARAZLOtazarotene | product | Jun 2036 |
| 11311482 | ARAZLOtazarotene | use | May 2038 |
| 12128137 | ARAZLOtazarotene | product | May 2038 |
| 12128059 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jul 2040 |
| 12133859 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jul 2040 |
| 12138278 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jul 2040 |
| 12616710 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Jul 2040 |
| 11389467 | CABTREOadapalene; benzoyl peroxide; clindamycin phosphate | product | Dec 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| CABTREOADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | NP New product | Oct 2026 |
Catalogue
Marketed products
93Showing 92 of 93.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ANCOBON | Flucytosine | capsule, oral | 0187-3554NDA |
| ANCOBON | Flucytosine | capsule, oral | 0187-3555NDA |
| Acanya | Clindamycin Phosphate and Benzoyl Peroxide | gel, topical | 13548-132NDA |
| Altreno | tretinoin | lotion, topical | 0187-0005NDA |
| Aplenzin | bupropion hydrobromide | tablet, extended release, oral | 0187-5810NDA |
| Aplenzin | bupropion hydrobromide | tablet, extended release, oral | 0187-5811NDA |
| Aplenzin | bupropion hydrobromide | tablet, extended release, oral | 0187-5812NDA |
| Arazlo | tazarotene | lotion, topical | 0187-2098NDA |
| Ativan | lorazepam | tablet, oral | 0187-0063NDA |
| Ativan | lorazepam | tablet, oral | 0187-0064NDA |
| Ativan | lorazepam | tablet, oral | 0187-0065NDA |
| Atralin | Tretinoin | gel, topical | 13548-070NDA |
| Benzamycin | erythromycin and benzoyl peroxide | kit | 0187-5205NDA |
| Bryhali | halobetasol propionate | lotion, topical | 0187-0002NDA |
| Cabtreo | clindamycin phosphate/benzoyl peroxide/adapalene | gel, topical | 0187-0006NDA |
| Caladryl | Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride | lotion, topical | 0187-5465OTC MONOGRAPH DRUG |
| Caladryl Clear | PRAMOXINE HYDROCHLORIDE and ZINC ACETATE | lotion, topical | 0187-5466OTC MONOGRAPH DRUG |
| Cardizem | Diltiazem Hydrochloride | tablet, coated, oral | 0187-0771NDA |
| Cardizem | Diltiazem Hydrochloride | tablet, coated, oral | 0187-0772NDA |
| Cardizem | Diltiazem Hydrochloride | tablet, coated, oral | 0187-0792NDA |
| Cardizem CD | diltiazem hydrochloride | capsule, coated, extended release, oral | 0187-0795NDA |
| Cardizem CD | diltiazem hydrochloride | capsule, coated, extended release, oral | 0187-0796NDA |
| Cardizem CD | diltiazem hydrochloride | capsule, coated, extended release, oral | 0187-0797NDA |
| Cardizem CD | diltiazem hydrochloride | capsule, coated, extended release, oral | 0187-0798NDA |
| Cardizem CD | diltiazem hydrochloride | capsule, coated, extended release, oral | 0187-0799NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2045NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2046NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2047NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2048NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2049NDA |
| Cardizem LA | Diltiazem Hydrochloride | tablet, extended release, oral | 0187-2050NDA |
| Cesamet | Nabilone | capsule, oral | 0187-1231NDA |
| Clindagel | CLINDAMYCIN | gel, topical | 16781-462NDA |
| Cuprimine | penicillamine | capsule, oral | 25010-705NDA |
| Demser | metyrosine | capsule, oral | 25010-305NDA |
| Duobrii | halobetasol propionate and tazarotene | lotion, topical | 0187-0653NDA |
| EDECRIN | ethacrynic acid | tablet, oral | 25010-215NDA |
| Efudex | Fluorouracil | cream, topical | 0187-3204NDA |
| JUBLIA | efinaconazole | solution, topical | 0187-5400NDA |
| Klaron | sulfacetamide sodium | lotion, topical | 0187-5198NDA |
| Librax | Chlordiazepoxide Hydrochloride and Clidinium Bromide | capsule, oral | 0187-4100NDA |
| Lodosyn | carbidopa | tablet, oral | 25010-711NDA |
| Luzu | LULICONAZOLE | cream, topical | 99207-850NDA |
| Mestinon | pyridostigmine bromide | tablet, oral | 0187-3010NDA |
| Mestinon | pyridostigmine bromide | solution, oral | 0187-3012NDA |
| Mestinon | pyridostigmine bromide | tablet, extended release, oral | 0187-3013NDA |
| Mysoline | Primidone | tablet, oral | 66490-690NDA |
| Mysoline | Primidone | tablet, oral | 66490-691NDA |
| Noritate | metronidazole | cream, topical | 0187-5202NDA |
| ONEXTON | Clindamycin Phosphate and Benzoyl Peroxide | gel, topical | 0187-3050NDA |
| Pepcid | famotidine | tablet, film coated, oral | 0187-4420ANDA |
| Pepcid | famotidine | tablet, film coated, oral | 0187-4440ANDA |
| Renova | Tretinoin | cream, topical | 0187-5150NDA |
| Retin-A | Tretinoin | cream, topical | 0187-5160NDA |
| Retin-A | Tretinoin | cream, topical | 0187-5162NDA |
| Retin-A | Tretinoin | cream, topical | 0187-5164NDA |
| Retin-A | Tretinoin | gel, topical | 0187-5170NDA |
| Retin-A | Tretinoin | gel, topical | 0187-5172NDA |
| Retin-A MICRO | Tretinoin | gel, topical | 0187-5140NDA |
| Retin-A MICRO | Tretinoin | gel, topical | 0187-5144NDA |
| Retin-A MICRO | Tretinoin | gel, topical | 0187-5146NDA |
| Retin-A MICRO | Tretinoin | gel, topical | 0187-5148NDA |
| Siliq | Brodalumab | injection, subcutaneous | 0187-0004BLA |
| Syprine | trientine hydrochloride | capsule, oral | 0187-2120NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2612NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2613NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2614NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2615NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2616NDA |
| TIAZAC EXTENDED RELEASE | diltiazem hydrochloride | capsule, extended release, oral | 0187-2617NDA |
| Targretin | bexarotene | gel, topical | 0187-5525NDA |
| Targretin | bexarotene | capsule, liquid filled, oral | 0187-5526NDA |
| Tasmar | Tolcapone | tablet, film coated, oral | 0187-0938NDA |
| Tetracaine Hydrochloride | Tetracaine Hydrochloride | solution/ drops, ophthalmic | 0187-0920NDA |
| TheraSeal | Dimethicone | cream, topical | 0187-1660OTC MONOGRAPH DRUG |
| Vaseretic | enalapril maleate and hydrochlorothiazide | tablet, oral | 0187-0146NDA |
| Vasotec | Enalapril Maleate | tablet, oral | 0187-0140NDA |
| Vasotec | Enalapril Maleate | tablet, oral | 0187-0141NDA |
| Vasotec | Enalapril Maleate | tablet, oral | 0187-0142NDA |
| Vasotec | Enalapril Maleate | tablet, oral | 0187-0143NDA |
| Visudyne | verteporfin for injection | injection, powder, lyophilized, for solution, intravenous | 0187-5600NDA |
| WELLBUTRIN XL | bupropion hydrochloride | tablet, extended release, oral | 0187-0730NDA |
| WELLBUTRIN XL | bupropion hydrochloride | tablet, extended release, oral | 0187-0731NDA |
| Xerese | Acyclovir and Hydrocortisone | cream, topical | 0187-5104NDA |
| ZELAPAR | SELEGILINE HYDROCHLORIDE | tablet, orally disintegrating, oral | 0187-0453NDA |
| ZIANA | clindamycin phosphate and tretinoin | gel, topical | 99207-300NDA |
| Zovirax | acyclovir | ointment, topical | 0187-0993NDA |
| Zovirax | acyclovir | cream, topical | 0187-0994NDA |
| Zyclara | imiquimod | cream, topical | 99207-270NDA |
| Zyclara | imiquimod | cream, topical | 99207-271NDA |
| Zyclara | imiquimod | cream, topical | 99207-276NDA |
| - | fluocinolone acetonide implant | implant | 71071-001BULK INGREDIENT |
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Enquiry
Common questions
- Is Bausch Health US, LLC FDA approved?
- Bausch Health US, LLC holds 1 FDA-registered establishment in Canada. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Bausch Health US, LLC's drugs manufactured?
- The FDA register lists Steinbach. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Bausch Health US, LLC make?
- 93 products are listed under Bausch Health US, LLC in the openFDA NDC Directory, most often as cream; gel; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.