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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091365
Company: DR REDDYS LABS LTD

Products on ANDA 091365

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091365

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2011	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/24/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/01/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091365

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091365	DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090799	FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204520	GLAND
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078339	HOSPIRA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202485	JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207575	SHILPA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078433	SUN PHARM
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078759	TEYRO LABS

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091365	DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090799	FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204520	GLAND
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078339	HOSPIRA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202485	JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207575	SHILPA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078433	SUN PHARM
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078759	TEYRO LABS

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