Register entry
Novitium Pharma LLC
- Registered sites
- 2
- Drug products
- 17
- Live patents
- 3
- Countries
- 2
- 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 |
|---|---|---|---|
| Novitium Labs Private Limited | ChennaiIndia | Analytical testing | 3013306721 |
| Novitium Pharma LLC | East Windsor, NJUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3012541241 |
Exclusivity
Patents
3Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| INZIRQO | HYDROCHLOROTHIAZIDE | Jan 2044 |
| TEZRULY | TERAZOSIN HYDROCHLORIDE | Feb 2041 |
Catalogue
Marketed products
17Showing 17 of 17.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Bisoprolol Fumarate | Bisoprolol Fumarate | TABLET | ANDA |
| Bisoprolol Fumarate | Bisoprolol Fumarate | TABLET | ANDA |
| Chlorzoxazone | Chlorzoxazone | TABLET | ANDA |
| Clotrimazole | Clotrimazole topical | SOLUTION | ANDA |
| Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | SOLUTION | ANDA |
| Estazolam | Estazolam | TABLET | ANDA |
| Estazolam | Estazolam | TABLET | ANDA |
| Felbamate | Felbamate | SUSPENSION | ANDA |
| Fludrocortisone Acetate | Fludrocortisone Acetate | TABLET | ANDA |
| Lidocaine Hydrochloride | Lidocaine Hydrochloride | SOLUTION | ANDA |
| Phenoxybenzamine Hydrochloride | Phenoxybenzamine Hydrochloride | CAPSULE | ANDA |
| Pyridostigmine | Pyridostigmine bromide oral | SOLUTION | ANDA |
| Selegiline Hydrochloride | Selegiline Hydrochloride | CAPSULE | ANDA |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET | ANDA |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET | ANDA |
| Tranylcypromine | Tranylcypromine | TABLET | ANDA |
| Trimethoprim | Trimethoprim | TABLET | 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.