Register entry
- Registered sites
- 5
- Active NDC listings
- 5
- Labeller names
- 4
- Live patents
- 32
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling5Finished drug manufacture4Packaging4
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Eagle Labs Inc | 8515 126TH Ave, Largo, Florida (FL) 33773, United States (USA) | Labelling, Finished drug manufacture, Packaging | 3038296155119508626 |
| Eagle Labs IncRegistrant: Eagle Labs Inc. | 630 Brooker Creek, Suite 350, Oldsmar, Florida (FL) 34677, United States (USA) | Labelling, Finished drug manufacture, Packaging | 3020295319189289965 |
| Eagle Labs Inc. | 10540 72nd St N, Seminole, Florida (FL) 33777, United States (USA) | Labelling, Finished drug manufacture, Packaging | 3005552050118496872 |
| Eagle Labs Inc | 6205 Johns Road SUITE 3-12, Tampa, Florida (FL) 33634, United States (USA) | Labelling, Finished drug manufacture, Packaging | 3019669808119272445 |
| Eagle Pharmaceuticals, Inc. | 50 Tice Boulevard - Suite 315, Woodcliff Lake, New Jersey (NJ) 07677, United States (USA) | Labelling | 3011077747849818161 |
Catalogue
Drug listings by form and route
55 active NDC listings: 3 human prescription drug, 2 human otc drug. By marketing category: NDA 3, OTC MONOGRAPH DRUG 2.
| Dosage form | NDCs |
|---|---|
| injection | 2 |
| cream | 1 |
| injection, suspension | 1 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| intravenous | 3 |
| topical | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| eagle pharmaceuticals, inc. | 2 |
| eagle labs inc | 1 |
| eagle labs inc. | 1 |
| eagle pharmaceuticals, inc | 1 |
Exclusivity
Patents and exclusivities
32| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10010533 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 11103483 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 11844783 | BELRAPZO, BENDEKAbendamustine hydrochloride | use | Jan 2031 |
| 11872214 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 12138248 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 12350257 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 9265831 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 9572796 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Jan 2031 |
| 9572797 | BELRAPZO, BENDEKAbendamustine hydrochloride | use | Jan 2031 |
| 8609707 | BELRAPZO, BENDEKAbendamustine hydrochloride | product | Aug 2031 |
| 10052385 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9000021 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9034908 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9144568 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9572887 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9579384 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9597397 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9597398 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9597399 | BENDEKAbendamustine hydrochloride | use | Mar 2033 |
| 9604990 | PEMFEXYpemetrexed | substance | Oct 2035 |
| 11793813 | PEMFEXYpemetrexed | product | Feb 2036 |
| 12115164 | PEMFEXYpemetrexed | use | Feb 2036 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BELRAPZO | bendamustine hydrochloride | injection, intravenous | 42367-521NDA |
| Healthy Back Institute Rub On Relief | Analgesic | cream, topical | 79804-618OTC MONOGRAPH DRUG |
| Pain Relief Roll On | Topical Analgesic | liquid, topical | 79804-282OTC MONOGRAPH DRUG |
| Pemfexy | pemetrexed | injection, intravenous | 42367-531NDA |
| RYANODEX dantrolene sodium | dantrolene sodium | injection, suspension, intravenous | 42367-540NDA |
Neighbours
Registered in the same town
11- AJENAT PHARMACEUTICALS LLCLargo, FL; Tampa, FL · 2 sites
- PETNET Solutions, Inc.TAMPA, FL
- Cardinal Health 418, Inc.Tampa, FL
- Lonza Biologics IncTAMPA, FL
- Bausch & Lomb Ireland LimitedTampa, FL
- Epic Laboratories, LLCTampa, FL
- BPI Labs, DBA Ally LabsLARGO, FL
- Jvet Pharmaceuticals LLCLargo, FL
- Kesin Pharma CorporationOldsmar, FL
- LiquidCapsule Manufacturing LLCTampa, FL
- Respitek IncTampa, FL
Compare
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- Mentholatum Company, The5 sites · 108 NDC
- American Regent, Inc.5 sites · 70 NDC
- Genzyme Corporation5 sites · 45 NDC
- Bora Pharmaceutical Laboratories Inc.5 sites · 15 NDC
- Jubilant DraxImage Inc., dba Jubilant Radiopharma5 sites · 11 NDC
- ILMO Products Company5 sites · 6 NDC
Enquiry
Common questions
- Is Eagle Pharmaceuticals, Inc. FDA approved?
- Eagle Pharmaceuticals, Inc. holds 5 FDA-registered establishments 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 Eagle Pharmaceuticals, Inc.'s drugs manufactured?
- The FDA register lists Largo, FL; Oldsmar, FL; Seminole, FL; Tampa, FL; Woodcliff Lake, NJ. Registered operations: labelling, finished drug manufacture, packaging.
- What drugs does Eagle Pharmaceuticals, Inc. make?
- 5 products are listed under Eagle Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection; cream; injection, suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
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.