Register entryShortage reported
Noven Pharmaceuticals, Inc.
- Registered sites
- 1
- Drug products
- 23
- Live patents
- 32
- 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 manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Miami, FLUnited States | Analytical testing, Finished drug manufacture | 1000222037 |
Alert
Products in shortage
4| Drug | Presentation | Availability |
|---|---|---|
| Methylphenidate Film, Extended Release | Methylphenidate, Film, Extended Release, 20 mg (NDC 0574-2420-65) | Available |
| Methylphenidate Film, Extended Release | Methylphenidate, Film, Extended Release, 30 mg (NDC 0574-2430-65) | Available |
| Methylphenidate Film, Extended Release | Methylphenidate, Film, Extended Release, 15 mg (NDC 0574-2415-65) | Available |
| Methylphenidate Film, Extended Release | Methylphenidate, Film, Extended Release, 10 mg (NDC 0574-2410-65) | Available |
Exclusivity
Patents
32Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| MINIVELLE | ESTRADIOL | Jul 2028 |
| MINIVELLE | ESTRADIOL | Jul 2030 |
| XELSTRYM | DEXTROAMPHETAMINE | Oct 2033 |
| XELSTRYM | DEXTROAMPHETAMINE | Mar 2034 |
| XELSTRYM | DEXTROAMPHETAMINE | Jan 2042 |
Catalogue
Marketed products
23Showing 23 of 23.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| CombiPatch (estradiol/norethindrone acetate transdermal system) | estradiol/norethindrone acetate transdermal system | PATCH, EXTENDED RELEASE | NDA |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | estradiol/norethindrone acetate transdermal system | PATCH, EXTENDED RELEASE | NDA |
| Daytrana | methylphenidate | PATCH | NDA |
| Daytrana | methylphenidate | PATCH | NDA |
| Daytrana | methylphenidate | PATCH | NDA |
| Daytrana | methylphenidate | PATCH | NDA |
| Estradiol | estradiol | FILM, EXTENDED RELEASE | NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | FILM, EXTENDED RELEASE | NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | FILM, EXTENDED RELEASE | NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | FILM, EXTENDED RELEASE | NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | FILM, EXTENDED RELEASE | NDA AUTHORIZED GENERIC |
| Minivelle | estradiol | FILM, EXTENDED RELEASE | NDA |
| Minivelle | estradiol | FILM, EXTENDED RELEASE | NDA |
| Minivelle | estradiol | FILM, EXTENDED RELEASE | NDA |
| Minivelle | estradiol | FILM, EXTENDED RELEASE | NDA |
| Minivelle | estradiol | FILM, EXTENDED RELEASE | NDA |
| SECUADO | ASENAPINE | FILM, EXTENDED RELEASE | NDA |
| SECUADO | ASENAPINE | FILM, EXTENDED RELEASE | NDA |
| SECUADO | ASENAPINE | FILM, EXTENDED RELEASE | NDA |
| XELSTRYM | DEXTROAMPHETAMINE | PATCH, EXTENDED RELEASE | NDA |
| XELSTRYM | DEXTROAMPHETAMINE | PATCH, EXTENDED RELEASE | NDA |
| XELSTRYM | DEXTROAMPHETAMINE | PATCH, EXTENDED RELEASE | NDA |
| XELSTRYM | DEXTROAMPHETAMINE | PATCH, EXTENDED RELEASE | NDA |
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.