اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER از شرکت HOSPIRA
New Drug Application (NDA): 018800
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/29/1982 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/06/2017 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf |
|
| 09/30/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/25/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 9MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088911 | FRESENIUS KABI USA |
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
| SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201850 | HIKMA PHARMS |
| SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206171 | SPECTRA MDCL DEVICES |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016677 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020178 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018803 | HOSPIRA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019465 | HOSPIRA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211968 | NEPHRON |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077407 | TARO |
نظرات کاربران