Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077425
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription AP No Yes
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) 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
08/29/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077425Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/18/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/29/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf

ADENOSINE

SOLUTION;IV (INFUSION); 60MG/20ML (3MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090212 SAGENT STRIDES
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 077425 TEVA PHARMS USA

SOLUTION;IV (INFUSION); 90MG/30ML (3MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090212 SAGENT STRIDES
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 077425 TEVA PHARMS 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