Drugs@FDA: FDA-Approved Drugs
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 |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English