Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202601
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription AP No No
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/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
02/20/2014 ORIG-1 Approval

Label is not available on this site.

CLONIDINE HYDROCHLORIDE

INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 200673 FRESENIUS KABI USA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 200300 HIKMA FARMACEUTICA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 203167 X-GEN PHARMS INC
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 202601 ZYDUS PHARMS
DURACLON CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020615 MYLAN INSTITUTIONAL

INJECTABLE;INJECTION; 5MG/10ML (0.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 200673 FRESENIUS KABI USA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 200300 HIKMA FARMACEUTICA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 203167 X-GEN PHARMS INC
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 202601 ZYDUS PHARMS
DURACLON CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020615 MYLAN INSTITUTIONAL

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