Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009435
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NESACAINE | CHLOROPROCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| NESACAINE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 3% | 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 |
|---|---|---|---|---|---|---|---|
| 03/11/1955 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009435s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009435Orig1s044Ltr.pdf | |
| 02/16/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2010 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf | |
| 02/19/2010 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf | |
| 06/21/2004 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09435slr034ltr.pdf | |
| 02/15/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/2000 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1996 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1993 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1990 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1990 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/12/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/16/1985 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/16/1985 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/23/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/23/1981 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/13/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/15/1974 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1976 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/16/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009435s044lbl.pdf | |
| 02/19/2010 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf | |
| 02/19/2010 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf | |
| 06/21/2004 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf |
NESACAINE
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 | 040273 | HIKMA |
| 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 |
NESACAINE-MPF
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 | 040273 | HIKMA |
| 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 |
INJECTABLE;INJECTION; 3%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE;INJECTION | Prescription | No | AP | 040273 | HIKMA |
| NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE;INJECTION | Prescription | Yes | AP | 009435 | FRESENIUS KABI USA |