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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205883
Company: AMNEAL PHARMS

Products on ANDA 205883

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205883

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205883Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/21/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/21/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/21/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/21/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 205883

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205883

MEROPENEM

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091404	ACS DOBFAR
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204139	ACS DOBFAR SPA
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205883	AMNEAL PHARMS
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216154	BROOKS STERISCIENCE
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205835	EUGIA PHARMA
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206141	GLAND
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210773	HQ SPCLT PHARMA
MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206086	SAVIOR LIFETEC CORP
MERREM	MEROPENEM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050706	PFIZER

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091404	ACS DOBFAR
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204139	ACS DOBFAR SPA
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205883	AMNEAL PHARMS
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216154	BROOKS STERISCIENCE
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205835	EUGIA PHARMA
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206141	GLAND
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210773	HQ SPCLT PHARMA
MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206086	SAVIOR LIFETEC CORP
MERREM	MEROPENEM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050706	PFIZER

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