Register entry
- Registered sites
- 2
- Active NDC listings
- 14
- Live patents
- 45
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing2Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| TOLMAR, INC.Registrant: TOLMAR Inc. | 2409 Research Blvd, Fort Collins, Colorado (CO) 80526, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3006218434015554360 |
| TOLMAR, INC.Registrant: TOLMAR Inc. | 9351 Eastman Park Drive, Windsor, Colorado (CO) 80550, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3010755927079806054 |
Catalogue
Drug listings by form and route
1414 active NDC listings: 14 human prescription drug. By marketing category: NDA 13, ANDA 1.
| Dosage form | NDCs |
|---|---|
| injection, suspension, extended release | 5 |
| kit | 5 |
| capsule, liquid filled | 3 |
| shampoo, suspension | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 9 |
| oral | 3 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| tolmar inc. | 14 |
Exclusivity
Patents and exclusivities
45| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11331325 | JATENZOtestosterone undecanoate | use | Jan 2027 |
| 8241664 | JATENZOtestosterone undecanoate | product | Mar 2029 |
| 10543219 | JATENZOtestosterone undecanoate | use | Apr 2030 |
| 10617696 | JATENZOtestosterone undecanoate | substance, product | Apr 2030 |
| 11179403 | JATENZOtestosterone undecanoate | use | Apr 2030 |
| 11426416 | JATENZOtestosterone undecanoate | use | Apr 2030 |
| 8778916 | JATENZOtestosterone undecanoate | product | Apr 2030 |
| 8492369 | JATENZOtestosterone undecanoate | product | Dec 2030 |
| 11564933 | JATENZOtestosterone undecanoate | use | Apr 2039 |
| 12605391 | JATENZOtestosterone undecanoate | use | Apr 2039 |
| 11771841 | ELIGARD KIT, FENSOLVI KITleuprolide acetate | substance, product | Dec 2041 |
| 11931559 | ELIGARD KIT, FENSOLVI KITleuprolide acetate | substance | Dec 2041 |
| 12397120 | ELIGARD KIT, FENSOLVI KITleuprolide acetate | use | Dec 2041 |
Catalogue
Marketed products
14| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ELIGARD | Leuprolide Acetate | kit, subcutaneous | 62935-223NDA |
| ELIGARD | Leuprolide Acetate | kit, subcutaneous | 62935-303NDA |
| ELIGARD | Leuprolide Acetate | kit, subcutaneous | 62935-453NDA |
| ELIGARD | Leuprolide Acetate | kit, subcutaneous | 62935-753NDA |
| Eligard | Leuprolide acetate | injection, suspension, extended release, subcutaneous | 62935-227NDA |
| Eligard | Leuprolide acetate | injection, suspension, extended release, subcutaneous | 62935-306NDA |
| Eligard | Leuprolide acetate | injection, suspension, extended release, subcutaneous | 62935-461NDA |
| Eligard | Leuprolide acetate | injection, suspension, extended release, subcutaneous | 62935-756NDA |
| Fensolvi | Leuprolide Acetate | kit | 62935-153NDA |
| Fensolvi | Leuprolide Acetate | injection, suspension, extended release, subcutaneous | 62935-163NDA |
| Jatenzo | testosterone undecanoate | capsule, liquid filled, oral | 69087-158NDA |
| Jatenzo | testosterone undecanoate | capsule, liquid filled, oral | 69087-198NDA |
| Jatenzo | testosterone undecanoate | capsule, liquid filled, oral | 69087-237NDA |
| Ketoconazole | Ketoconazole | shampoo, suspension, topical | 63646-010ANDA |
Neighbours
Registered in the same town
1- Reliant Holdings, LtdWindsor, CO
Compare
Comparable companies in United States
- Deseret Laboratories Incorporated2 sites · 858 NDC
- Padagis Israel Pharmaceuticals Ltd2 sites · 236 NDC
- PureTek Corporation2 sites · 178 NDC
- Cosmax Usa Corporation2 sites · 142 NDC
- Apotheca Company2 sites · 110 NDC
- Nivagen Pharmaceuticals LLC2 sites · 106 NDC
- GOJO Industries, LLC2 sites · 84 NDC
- KVK-TECH, INC.2 sites · 71 NDC
- Revlon Consumer Products Corporation2 sites · 61 NDC
- Samsung Biologics Co., Ltd.2 sites · 57 NDC
Enquiry
Common questions
- Is TOLMAR Inc. FDA approved?
- TOLMAR Inc. holds 2 FDA-registered establishments in the United States. 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 TOLMAR Inc.'s drugs manufactured?
- The FDA register lists Fort Collins, CO; Windsor, CO. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does TOLMAR Inc. make?
- 14 products are listed under TOLMAR Inc. in the openFDA NDC Directory, most often as injection, suspension, extended release; kit; capsule, liquid filled. 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.