Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080658
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Discontinued None No No
PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Discontinued None 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
04/01/1974 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
02/19/1999 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/26/1996 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/10/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/27/1994 SUPPL-15 Labeling

Label is not available on this site.

09/27/1994 SUPPL-14 Labeling

Label is not available on this site.

12/23/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/25/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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