Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 087447
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/16/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/03/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 2%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 087447 | HOSPIRA |
| CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 040273 | WEST-WARD PHARMS INT |
| NESACAINE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 009435 | FRESENIUS KABI USA |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 009435 | FRESENIUS KABI USA |
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