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
CHROMIC CHLORIDE IN PLASTIC CONTAINER از شرکت HOSPIRA
New Drug Application (NDA): 018961
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHROMIC CHLORIDE IN PLASTIC CONTAINER | CHROMIC CHLORIDE | EQ 0.004MG CHROMIUM/ML | INJECTABLE;INJECTION | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 06/26/1986 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/2002 | SUPPL-12 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18961s012.pdf |
||
| 02/16/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/09/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/22/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/10/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1987 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/09/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/24/2002 | SUPPL-12 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf |
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