Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091358
Company: MYLAN LABS LTD

Products on ANDA 091358

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091358

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2017	ORIG-2	Approval				Label is not available on this site.
08/07/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091358Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-12	Labeling-Package Insert, Labeling		Label is not available on this site.
03/08/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091358

OXALIPLATIN

INJECTABLE;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207474	ACCORD HLTHCARE
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078811	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207325	GLAND
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	217925	HETERO LABS LTD VI
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078813	HOSPIRA WORLDWIDE
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	217348	MEITHEAL
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091358	MYLAN LABS LTD
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204368	QILU PHARM HAINAN
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078817	SANDOZ
OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219765	SHANDONG

INJECTABLE;INTRAVENOUS; 100MG/20ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207474	ACCORD HLTHCARE
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078811	FRESENIUS KABI USA
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207325	GLAND
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	217925	HETERO LABS LTD VI
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078813	HOSPIRA WORLDWIDE
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	217348	MEITHEAL
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091358	MYLAN LABS LTD
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204368	QILU PHARM HAINAN
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	078817	SANDOZ
OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219765	SHANDONG