Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040140
Company: HOSPIRA
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 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
11/20/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40140ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/040140.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/13/2006 SUPPL-9 Labeling

Label is not available on this site.

11/12/2002 SUPPL-4 Labeling

Label is not available on this site.

02/14/2001 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/07/2000 SUPPL-1 Manufacturing (CMC)-Control

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

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