Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075792
Company: ATHENEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 1MG/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
08/29/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75792ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/09/2008 SUPPL-8 Labeling

Label is not available on this site.

05/01/2007 SUPPL-7 Labeling

Label is not available on this site.

03/13/2002 SUPPL-2 Labeling

Label is not available on this site.

04/03/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

PROPRANOLOL HYDROCHLORIDE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075792 ATHENEX INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075826 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