Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087702
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription AP No 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
09/07/1982 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
07/03/2014 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

01/07/2003 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/07/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/15/1995 SUPPL-20 Labeling

Label is not available on this site.

04/19/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/27/1994 SUPPL-18 Labeling

Label is not available on this site.

10/28/1991 SUPPL-17 Labeling

Label is not available on this site.

06/12/1991 SUPPL-16 Labeling

Label is not available on this site.

01/14/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/21/1989 SUPPL-13 Labeling

Label is not available on this site.

05/26/1989 SUPPL-12 Labeling

Label is not available on this site.

05/26/1989 SUPPL-11 Labeling

Label is not available on this site.

02/07/1989 SUPPL-10 Labeling

Label is not available on this site.

04/02/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/21/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/21/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/21/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/27/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION; EQ 10MG PHOSPHATE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 210967 AUROBINDO PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040572 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 209192 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040802 MYLAN LABS LTD
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 211036 SOMERSET THERAPS LLC
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 087702 WEST-WARD PHARMS INT
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 208690 AMNEAL PHARMS CO
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 040491 FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML INJECTABLE;INJECTION Prescription No AP 207442 SOMERSET THERAPS LLC

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