Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077297
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION 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
06/30/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf
05/30/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/13/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077297Orig1s010.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf
04/13/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079078 AKORN INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204238 AUROBINDO PHARMA LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078880 BIONPHARMA INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078258 CIPLA LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077297 DR REDDYS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078090 FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078629 HIKMA FARMACEUTICA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091137 MYLAN ASI
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203453 MYLAN LABS LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078531 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078835 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077177 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077186 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078565 WOCKHARDT USA

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