Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084779
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML 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
03/15/1982 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
04/16/2007 SUPPL-19 Labeling

Label is not available on this site.

02/19/1999 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/20/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/03/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/16/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/12/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/27/1990 SUPPL-11 Labeling

Label is not available on this site.

11/18/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/18/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-6 Bioequivalence

Label is not available on this site.

05/28/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ORPHENADRINE CITRATE

INJECTABLE;INJECTION; 30MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 040484 AKORN
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 090585 SAGENT PHARMS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 084779 WATSON LABS
ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION Prescription No AP 040463 WEST-WARD PHARMS INT

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