Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080817
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/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
11/27/1972 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
11/05/2002 SUPPL-41 Labeling

Label is not available on this site.

10/01/1999 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1998 SUPPL-39 Labeling

Label is not available on this site.

02/11/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/29/1998 SUPPL-36 Labeling

Label is not available on this site.

06/08/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/17/1993 SUPPL-34 Labeling

Label is not available on this site.

10/30/1992 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/05/1990 SUPPL-32 Labeling

Label is not available on this site.

07/23/1992 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/07/1990 SUPPL-29 Labeling

Label is not available on this site.

11/23/1988 SUPPL-28 Labeling

Label is not available on this site.

11/03/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/10/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/08/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040466 APP PHARMS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040140 HOSPIRA
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 205723 MICRO LABS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 040498 MYLAN INSTITUTIONAL
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 080817 WEST-WARD PHARMS INT
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 091526 FRESENIUS KABI USA

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