Register entry
- Registered sites
- 1
- Active NDC listings
- 82
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Leading Pharma, LLC | 3 Oak Rd, Fairfield, New Jersey (NJ) 07004, United States (USA) | Analytical testing, Finished drug manufacture, Packaging | 3001611969079575060 |
Catalogue
Drug listings by form and route
8282 active NDC listings: 82 human prescription drug. By marketing category: ANDA 78, NDA AUTHORIZED GENERIC 2, UNAPPROVED DRUG OTHER 2.
| Dosage form | NDCs |
|---|---|
| tablet | 31 |
| capsule | 13 |
| solution | 11 |
| tablet, film coated | 11 |
| tablet, extended release | 3 |
| capsule, delayed release | 2 |
| suspension | 2 |
| capsule, liquid filled | 1 |
| cream | 1 |
| emulsion | 1 |
| injection, powder, lyophilized, for solution | 1 |
| kit | 1 |
| ointment | 1 |
| powder | 1 |
| powder, for solution | 1 |
| Route | NDCs |
|---|---|
| oral | 65 |
| ophthalmic | 11 |
| topical | 3 |
| auricular (otic) | 1 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| leading pharma, llc | 80 |
| leading pharmaceuticals, llc | 2 |
Catalogue
Marketed products
82| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Allopurinol | Allopurinol | tablet, oral | 69315-291ANDA |
| Allopurinol | Allopurinol | tablet, oral | 69315-292ANDA |
| Allopurinol | Allopurinol | tablet, oral | 69315-409ANDA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | tablet, oral | 69315-136ANDA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | tablet, oral | 69315-137ANDA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | tablet, oral | 69315-138ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | solution, ophthalmic | 69315-330ANDA |
| CARBINOXAMINE MALEATE | CARBINOXAMINE MALEATE | tablet, oral | 69315-239ANDA |
| Clomipramine Hydrochloride | Clomipramine Hydrochloride | capsule, oral | 69315-165ANDA |
| Clomipramine Hydrochloride | Clomipramine Hydrochloride | capsule, oral | 69315-166ANDA |
| Clomipramine Hydrochloride | Clomipramine Hydrochloride | capsule, oral | 69315-167ANDA |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | powder, for solution, oral | 69315-506NDA AUTHORIZED GENERIC |
| DIFLUPREDNATE | DIFLUPREDNATE | emulsion, ophthalmic | 69315-329ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-158ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-159ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-160ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-161ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-162ANDA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | capsule, oral | 69315-163ANDA |
| Diclofenac Potassium | Diclofenac Potassium | capsule, liquid filled, oral | 69315-275NDA AUTHORIZED GENERIC |
| Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | tablet, oral | 69315-910ANDA |
| Dorzolamide and Timolol | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution | solution, ophthalmic | 69315-305ANDA |
| Dorzolamide hydrochloride | Dorzolamide hydrochloride | solution, ophthalmic | 69315-304ANDA |
| ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE | ESTERIFIED ESTROGENS, METHYLTESTOSTERONE | tablet, oral | 69315-283UNAPPROVED DRUG OTHER |
| ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE | ESTERIFIED ESTROGENS, METHYLTESTOSTERONE | tablet, oral | 69315-284UNAPPROVED DRUG OTHER |
| ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | injection, powder, lyophilized, for solution, intravenous | 69315-701ANDA |
| ETRAVIRINE | ETRAVIRINE | tablet, oral | 69315-285ANDA |
| ETRAVIRINE | ETRAVIRINE | tablet, oral | 69315-286ANDA |
| FENOFIBRIC ACID | FENOFIBRIC ACID | capsule, delayed release, oral | 69315-281ANDA |
| FENOFIBRIC ACID | FENOFIBRIC ACID | capsule, delayed release, oral | 69315-282ANDA |
| FOLIC ACID | FOLIC ACID | tablet, oral | 69315-127ANDA |
| FROVATRIPTAN SUCCINATE | FROVATRIPTAN SUCCINATE | tablet, film coated, oral | 69315-157ANDA |
| Fenofibrate | Fenofibrate | tablet, film coated, oral | 69315-289ANDA |
| Fenofibrate | Fenofibrate | tablet, film coated, oral | 69315-290ANDA |
| Furosemide | Furosemide | tablet, oral | 69315-116ANDA |
| Furosemide | Furosemide | tablet, oral | 69315-117ANDA |
| Furosemide | Furosemide | tablet, oral | 69315-118ANDA |
| GATIFLOXACIN | GATIFLOXACIN | solution, ophthalmic | 69315-331ANDA |
| Glycopyrrolate | Glycopyrrolate | tablet, oral | 69315-139ANDA |
| Glycopyrrolate | Glycopyrrolate | tablet, oral | 69315-140ANDA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | tablet, oral | 69315-130ANDA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | tablet, oral | 69315-131ANDA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | tablet, oral | 69315-155ANDA |
| HYDROXYUREA | HYDROXYUREA | capsule, oral | 69315-164ANDA |
| Imipramine Hydrochloride | Imipramine Hydrochloride | tablet, film coated, oral | 69315-133ANDA |
| Imipramine Hydrochloride | Imipramine Hydrochloride | tablet, film coated, oral | 69315-134ANDA |
| Imipramine Hydrochloride | Imipramine Hydrochloride | tablet, film coated, oral | 69315-135ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | tablet, film coated, oral | 69315-260ANDA |
| Ketorolac Tromethamine | Ketorolac Tromethamine | solution/ drops, ophthalmic | 69315-322ANDA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | tablet, oral | 69315-184ANDA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | tablet, oral | 69315-185ANDA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | tablet, oral | 69315-186ANDA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | tablet, oral | 69315-187ANDA |
| Lacosamide | Lacosamide | solution, oral | 69315-318ANDA |
| Lorazepam | Lorazepam | tablet, oral | 69315-904ANDA |
| Lorazepam | Lorazepam | tablet, oral | 69315-905ANDA |
| Lorazepam | Lorazepam | tablet, oral | 69315-906ANDA |
| METFORMIN HYDROCHLORIDE ER | metformin hydrochloride | tablet, extended release, oral | 69315-410ANDA |
| NYSTATIN | NYSTATIN | powder, topical | 69315-306ANDA |
| NYSTATIN | NYSTATIN | ointment, topical | 69315-307ANDA |
| NYSTATIN | NYSTATIN | suspension, oral | 69315-504ANDA |
| OFLOXACIN | OFLOXACIN | solution, auricular (otic) | 69315-320ANDA |
| OFLOXACIN | OFLOXACIN | solution, ophthalmic | 69315-327ANDA |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | suspension, oral | 69315-174ANDA |
| OXAZEPAM | OXAZEPAM | capsule, oral | 69315-911ANDA |
| OXAZEPAM | OXAZEPAM | capsule, oral | 69315-912ANDA |
| OXAZEPAM | OXAZEPAM | capsule, oral | 69315-913ANDA |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | tablet, oral | 69315-182ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | solution, ophthalmic | 69315-323ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | solution, ophthalmic | 69315-324ANDA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | tablet, film coated, oral | 69315-265ANDA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | tablet, film coated, oral | 69315-266ANDA |
| Procto-Med HC | HYDROCORTISONE | cream, topical | 69315-312ANDA |
| THEOPHYLLINE | THEOPHYLLINE | tablet, extended release, oral | 69315-226ANDA |
| THEOPHYLLINE | THEOPHYLLINE | tablet, extended release, oral | 69315-227ANDA |
| TIMOLOL MALEATE | TIMOLOL MALEATE | solution, ophthalmic | 69315-325ANDA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | tablet, film coated, oral | 69315-402ANDA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | tablet, film coated, oral | 69315-403ANDA |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | kit | 69315-404ANDA |
| ciprofloxacin | Ciprofloxacin | solution, ophthalmic | 69315-308ANDA |
| fenofibrate | fenofibrate | tablet, oral | 69315-287ANDA |
| fenofibrate | fenofibrate | tablet, oral | 69315-288ANDA |
Neighbours
Registered in the same town
7- SGS North America Inc.Fairfield, NJ
- Teva Pharmaceutical Industries Ltd.Fairfield, NJ
- API Solutions Inc.Fairfield, NJ
- Aarkish Pharmaceuticals NJ IncFairfield, NJ
- Akron Pharma Inc.Fairfield, NJ
- GRANULATION TECHNOLOGY, INC.FAIRFIELD, NJ
- Garonit Pharmaceutical, Inc.Fairfield, NJ
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Enquiry
Common questions
- Is Leading Pharma, LLC FDA approved?
- Leading Pharma, LLC 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 Leading Pharma, LLC's drugs manufactured?
- The FDA register lists Fairfield, NJ. Registered operations: analytical testing, finished drug manufacture, packaging.
- What drugs does Leading Pharma, LLC make?
- 82 products are listed under Leading Pharma, LLC in the openFDA NDC Directory, most often as tablet; capsule; solution. 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.