Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040273
Company: HIKMA
Company: HIKMA
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 |
CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 3% | 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 |
---|---|---|---|---|---|---|---|
09/09/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40273ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/07/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2001 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
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 | 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 |