Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 200795
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription AP Yes 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
08/04/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200795s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200795s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795_gemcitabine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200795Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200795s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200795Orig1s008ltr.pdf
04/07/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/08/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200795s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200795Orig1s005ltr.pdf
09/05/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200795s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200795Orig1s004ltr.pdf
11/27/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/20/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/18/2012 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200795s008lbl.pdf
05/08/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200795s005lbl.pdf
09/05/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200795s004lbl.pdf
08/04/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200795s000lbl.pdf

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; 200MG/5.26ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

INJECTABLE;INJECTION; 1GM/26.3ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

INJECTABLE;INJECTION; 2GM/52.6ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

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