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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090577
Company: ACS DOBFAR

Products on ANDA 090577

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	No	Yes
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090577

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2011	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
02/05/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/09/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/09/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/29/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/29/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090577

IMIPENEM AND CILASTATIN

POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL;500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090577	ACS DOBFAR
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207594	HQ SPCLT PHARMA
PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	050587	MERCK

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