Register entry
Shandong New Time Pharmaceutical Co., Ltd.
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 29
- Live patents
- 0
- Countries
- 1
- Base
- China
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Shandong New Time Pharmaceutical Co., Ltd. | No. 1, North Outer Ring Road, Feixian, Linyi, Shandong 273499, China (CHN) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3006704412545298254 |
Catalogue
Drug listings by form and route
2929 active NDC listings: 20 human prescription drug, 5 bulk ingredient, 4 drug for further processing. By marketing category: ANDA 20, BULK INGREDIENT 4, DRUG FOR FURTHER PROCESSING 4, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 7 |
| powder | 7 |
| liquid | 5 |
| tablet, film coated | 4 |
| capsule | 3 |
| tablet, extended release | 3 |
| Route | NDCs |
|---|---|
| oral | 10 |
| intravenous | 7 |
| respiratory (inhalation) | 3 |
| Labeller name on the listing | NDCs |
|---|---|
| shandong new time pharmaceutical co., ltd. | 29 |
Catalogue
Marketed products
29| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM | powder | 42677-108DRUG FOR FURTHER PROCESSING |
| - | CLAVULANATE POTASSIUM | powder | 42677-104DRUG FOR FURTHER PROCESSING |
| - | CLAVULANATE POTASSIUM | powder | 42677-105BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | ISOSORBIDE MONONITRATE | powder | 42677-101DRUG FOR FURTHER PROCESSING |
| - | ISOSORBIDE MONONITRATE | powder | 42677-102DRUG FOR FURTHER PROCESSING |
| - | Isoflurane | liquid | 42677-114BULK INGREDIENT |
| Isoflurane | Isoflurane | liquid, respiratory (inhalation) | 42677-326ANDA |
| Isoflurane | Isoflurane | liquid, respiratory (inhalation) | 42677-327ANDA |
| Isosorbide Mononitrate | Isosorbide Mononitrate | tablet, extended release, oral | 42677-305ANDA |
| Isosorbide Mononitrate | Isosorbide Mononitrate | tablet, extended release, oral | 42677-306ANDA |
| Isosorbide Mononitrate | Isosorbide Mononitrate | tablet, extended release, oral | 42677-307ANDA |
| - | Milrinone | powder | 42677-107BULK INGREDIENT |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 42677-313ANDA |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 42677-314ANDA |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 42677-338ANDA |
| - | Orlistat | powder | 42677-119BULK INGREDIENT |
| Oseltamivir phosphate | Oseltamivir phosphate | capsule, oral | 42677-320ANDA |
| Oseltamivir phosphate | Oseltamivir phosphate | capsule, oral | 42677-321ANDA |
| Oseltamivir phosphate | Oseltamivir phosphate | capsule, oral | 42677-322ANDA |
| Rocuronium Bromide | Rocuronium Bromide | injection, solution, intravenous | 42677-309ANDA |
| Rocuronium Bromide | Rocuronium Bromide | injection, solution, intravenous | 42677-310ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, film coated, oral | 42677-301ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, film coated, oral | 42677-302ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, film coated, oral | 42677-303ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, film coated, oral | 42677-304ANDA |
| Sevoflurane | Sevoflurane | liquid, respiratory (inhalation) | 42677-308ANDA |
| oxaliplatin | oxaliplatin | injection, solution, intravenous | 42677-336ANDA |
| oxaliplatin | oxaliplatin | injection, solution, intravenous | 42677-337ANDA |
| - | sevoflurane | liquid | 42677-110BULK INGREDIENT |
Neighbours
Registered in the same town
1- Shandong Yayun Sanitary Products Co LtdLinyi, CHN
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Enquiry
Common questions
- Is Shandong New Time Pharmaceutical Co., Ltd. FDA approved?
- Shandong New Time Pharmaceutical Co., Ltd. holds 1 FDA-registered establishment in China. 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 Shandong New Time Pharmaceutical Co., Ltd.'s drugs manufactured?
- The FDA register lists Linyi. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Shandong New Time Pharmaceutical Co., Ltd. make?
- 29 products are listed under Shandong New Time Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection, solution; powder; liquid. 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.