Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 23
- Live patents
- 32
- Shortage listings
- 4
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | 11960 SW 144 Street, Miami, Florida (FL) 33186, United States (USA) | Analytical testing, Finished drug manufacture | 1000222037148585441 |
Alert
Drug shortage listings
4| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Methylphenidate Film, Extended ReleasePsychiatry | Methylphenidate, Film, Extended Release, 20 mg (NDC 0574-2420-65) | Current | Available | 28 Feb 20252 Sept 2026 |
| Methylphenidate Film, Extended ReleasePsychiatry | Methylphenidate, Film, Extended Release, 30 mg (NDC 0574-2430-65) | Current | Available | 28 Feb 20252 Sept 2026 |
| Methylphenidate Film, Extended ReleasePsychiatry | Methylphenidate, Film, Extended Release, 15 mg (NDC 0574-2415-65) | Current | Available | 28 Feb 20252 Sept 2026 |
| Methylphenidate Film, Extended ReleasePsychiatry | Methylphenidate, Film, Extended Release, 10 mg (NDC 0574-2410-65) | Current | Available | 28 Feb 20252 Sept 2026 |
Catalogue
Drug listings by form and route
2323 active NDC listings: 23 human prescription drug. By marketing category: NDA 18, NDA AUTHORIZED GENERIC 5.
| Dosage form | NDCs |
|---|---|
| film, extended release | 13 |
| patch, extended release | 6 |
| patch | 4 |
| Route | NDCs |
|---|---|
| transdermal | 23 |
| Labeller name on the listing | NDCs |
|---|---|
| noven therapeutics, llc | 23 |
Exclusivity
Patents and exclusivities
32| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9724310 | MINIVELLEestradiol | substance, product | Jul 2028 |
| 9730900 | MINIVELLEestradiol | product | Jul 2028 |
| 9833419 | MINIVELLEestradiol | product | Jul 2028 |
| 8231906 | MINIVELLEestradiol | substance, product | Jul 2030 |
| 9456993 | XELSTRYMdextroamphetamine | product | Oct 2033 |
| 9474722 | XELSTRYMdextroamphetamine | product | Oct 2033 |
| 12678504 | XELSTRYMdextroamphetamine | product | Mar 2034 |
| 11559501 | XELSTRYMdextroamphetamine | product | Jan 2042 |
Catalogue
Marketed products
23| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CombiPatch (estradiol/norethindrone acetate transdermal system) | estradiol/norethindrone acetate transdermal system | patch, extended release, transdermal | 68968-0514NDA |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | estradiol/norethindrone acetate transdermal system | patch, extended release, transdermal | 68968-0525NDA |
| Daytrana | methylphenidate | patch, transdermal | 68968-5552NDA |
| Daytrana | methylphenidate | patch, transdermal | 68968-5553NDA |
| Daytrana | methylphenidate | patch, transdermal | 68968-5554NDA |
| Daytrana | methylphenidate | patch, transdermal | 68968-5555NDA |
| Estradiol | estradiol | film, extended release, transdermal | 68968-3410NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | film, extended release, transdermal | 68968-3425NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | film, extended release, transdermal | 68968-3437NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | film, extended release, transdermal | 68968-3450NDA AUTHORIZED GENERIC |
| Estradiol | estradiol | film, extended release, transdermal | 68968-3475NDA AUTHORIZED GENERIC |
| Minivelle | estradiol | film, extended release, transdermal | 68968-6610NDA |
| Minivelle | estradiol | film, extended release, transdermal | 68968-6625NDA |
| Minivelle | estradiol | film, extended release, transdermal | 68968-6637NDA |
| Minivelle | estradiol | film, extended release, transdermal | 68968-6650NDA |
| Minivelle | estradiol | film, extended release, transdermal | 68968-6675NDA |
| SECUADO | ASENAPINE | film, extended release, transdermal | 68968-0172NDA |
| SECUADO | ASENAPINE | film, extended release, transdermal | 68968-0173NDA |
| SECUADO | ASENAPINE | film, extended release, transdermal | 68968-0174NDA |
| XELSTRYM | DEXTROAMPHETAMINE | patch, extended release, transdermal | 68968-0205NDA |
| XELSTRYM | DEXTROAMPHETAMINE | patch, extended release, transdermal | 68968-0210NDA |
| XELSTRYM | DEXTROAMPHETAMINE | patch, extended release, transdermal | 68968-0215NDA |
| XELSTRYM | DEXTROAMPHETAMINE | patch, extended release, transdermal | 68968-0220NDA |
Neighbours
Registered in the same town
12- Ionetix CorporationMiami, FL · 2 sites
- P & L Development, LLCMiami, FL
- Prime Enterprises, LLC dba Prime Matter LabsMiami, FL
- Medipharm Laboratories, IncMiami, FL
- Advanced Generic CorporationMiami, FL
- Aldama Pharmaceuticals IncMiami, FL
- Alternative Pharmacal CorporationMiami, FL
- Dextrum Laboratories Inc.Miami, FL
- Dharma Research, Inc.Miami, FL
- Fridababy, LLCMiami, FL
- GADAL Laboratories, IncMiami, FL
- Germa Products LLCMIAMI, FL
Compare
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- ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
- Golden State Medical Supply Inc.1 site · 670 NDC
- Rising Pharma Holdings, Inc.1 site · 532 NDC
- HF Acquisition Co LLC1 site · 363 NDC
- ANI Pharmaceuticals, Inc.1 site · 299 NDC
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
- Newton Laboratories, Inc.1 site · 271 NDC
Enquiry
Common questions
- Is Noven Pharmaceuticals, Inc. FDA approved?
- Noven Pharmaceuticals, Inc. holds 1 FDA-registered establishment 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 Noven Pharmaceuticals, Inc.'s drugs manufactured?
- The FDA register lists Miami, FL. Registered operations: analytical testing, finished drug manufacture.
- What drugs does Noven Pharmaceuticals, Inc. make?
- 23 products are listed under Noven Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as film, extended release; patch, extended release; patch. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Noven Pharmaceuticals, Inc. products in shortage?
- 4 presentations are currently listed in the FDA drug shortage database under Noven Pharmaceuticals, Inc., covering Methylphenidate Film, Extended Release.
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.