Register entry
Novel Laboratories Inc
- Registered sites
- 1
- Drug products
- 22
- Live patents
- 0
- 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 testingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJUnited States | Analytical testing, Finished drug manufacture, Packaging | 3006271438 |
Catalogue
Marketed products
22Showing 22 of 22.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Carbidopa | Carbidopa | TABLET | ANDA |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | SOLUTION | ANDA |
| Desoximetasone | desoximetasone | OINTMENT | ANDA |
| Doxycycline Hyclate | Doxycycline Hyclate | TABLET | ANDA |
| Flucytosine | Flucytosine | CAPSULE | ANDA |
| Flucytosine | Flucytosine | CAPSULE | ANDA |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | TABLET | ANDA |
| Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | SYRUP | ANDA |
| Levonorgestrel | Levonorgestrel | TABLET | ANDA |
| Misoprostol | Misoprostol | TABLET | ANDA |
| Misoprostol | Misoprostol | TABLET | ANDA |
| Nitrofurantoin | Nitrofurantoin | SUSPENSION | ANDA |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | CAPSULE | ANDA |
| POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | POWDER, FOR SOLUTION | ANDA |
| Potassium Chloride | Potassium Chloride | FOR SOLUTION | ANDA |
| SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE | sodium sulfate, potassium sulfate, magnesium sulfate | SOLUTION | ANDA |
| Trimethoprim | Trimethoprim | TABLET | ANDA |
| VORICONAZOLE | voriconazole | SUSPENSION | ANDA |
| cevimeline hydrochloride | cevimeline hydrochloride | CAPSULE | ANDA |
| clobetasol propionate | clobetasol propionate | SOLUTION | ANDA |
| clobetasol propionate | clobetasol propionate | OINTMENT | ANDA |
| fluocinonide | fluocinonide | SOLUTION | 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.