Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076133
Company: DR REDDYS LABS LTD

Products on ANDA 076133

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	AB	No	No
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2012	ORIG-2	Approval				Label is not available on this site.
10/24/2011	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
02/09/2023	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
11/09/2020	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/20/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/20/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076133

OLANZAPINE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	202295	ALKEM LABS LTD
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	090798	APOTEX INC
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	202050	AUROBINDO PHARMA LTD
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	210022	CADILA PHARMS LTD
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	203333	CHARTWELL MOLECULAR
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	076133	DR REDDYS LABS LTD
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	202862	MACLEODS PHARMS LTD
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	202287	ORBION PHARMS
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	204319	QILU
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	091038	SUN PHARM INDS
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Prescription	No	AB	090459	ZYDUS PHARMS
ZYPREXA	OLANZAPINE	15MG	TABLET;ORAL	Prescription	Yes	AB	020592	CHEPLAPHARM

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	202295	ALKEM LABS LTD
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	090798	APOTEX INC
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	202050	AUROBINDO PHARMA LTD
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	210022	CADILA PHARMS LTD
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	203333	CHARTWELL MOLECULAR
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	076133	DR REDDYS LABS LTD
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	202862	MACLEODS PHARMS LTD
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	202287	ORBION PHARMS
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	204319	QILU
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	091038	SUN PHARM INDS
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Prescription	No	AB	090459	ZYDUS PHARMS
ZYPREXA	OLANZAPINE	20MG	TABLET;ORAL	Prescription	Yes	AB	020592	CHEPLAPHARM