Register entry
TOLMAR Inc.
- Registered sites
- 2
- Drug products
- 14
- Live patents
- 45
- Countries
- 1
- Base
- United States
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
2| Site | Location | Operations | FEI |
|---|---|---|---|
| TOLMAR, INC. | Fort Collins, COUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3006218434 |
| TOLMAR, INC. | Windsor, COUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3010755927 |
Exclusivity
Patents
45Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ELIGARD KIT | LEUPROLIDE ACETATE | Dec 2041 |
| FENSOLVI KIT | LEUPROLIDE ACETATE | Dec 2041 |
| JATENZO | TESTOSTERONE UNDECANOATE | Jan 2027 |
| JATENZO | TESTOSTERONE UNDECANOATE | Mar 2029 |
| JATENZO | TESTOSTERONE UNDECANOATE | Apr 2030 |
| JATENZO | TESTOSTERONE UNDECANOATE | Dec 2030 |
| JATENZO | TESTOSTERONE UNDECANOATE | Apr 2039 |
Catalogue
Marketed products
14Showing 14 of 14.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ELIGARD | Leuprolide Acetate | KIT | NDA |
| ELIGARD | Leuprolide Acetate | KIT | NDA |
| ELIGARD | Leuprolide Acetate | KIT | NDA |
| ELIGARD | Leuprolide Acetate | KIT | NDA |
| Eligard | Leuprolide acetate | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Eligard | Leuprolide acetate | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Eligard | Leuprolide acetate | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Eligard | Leuprolide acetate | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Fensolvi | Leuprolide Acetate | KIT | NDA |
| Fensolvi | Leuprolide Acetate | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Jatenzo | testosterone undecanoate | CAPSULE, LIQUID FILLED | NDA |
| Jatenzo | testosterone undecanoate | CAPSULE, LIQUID FILLED | NDA |
| Jatenzo | testosterone undecanoate | CAPSULE, LIQUID FILLED | NDA |
| Ketoconazole | Ketoconazole | SHAMPOO, SUSPENSION | 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.