Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018960
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUPRIC CHLORIDE IN PLASTIC CONTAINER | CUPRIC CHLORIDE | EQ 0.4MG COPPER/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 |
|---|---|---|---|---|---|---|---|
| 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-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2003 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18960slr013ltr.pdf |
| 02/16/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/22/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-8 | Labeling |
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. |
CUPRIC CHLORIDE IN PLASTIC CONTAINER
INJECTABLE;INJECTION; EQ 0.4MG COPPER/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CUPRIC CHLORIDE | CUPRIC CHLORIDE | EQ 0.4MG COPPER/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212071 | EXELA PHARMA |
| CUPRIC CHLORIDE IN PLASTIC CONTAINER | CUPRIC CHLORIDE | EQ 0.4MG COPPER/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018960 | HOSPIRA |