Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208600
Company: AMPHASTAR PHARMS INC

Products on ANDA 208600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208600

ENOXAPARIN SODIUM

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 300MG/3ML (100MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AB	208600	AMPHASTAR PHARMS INC
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AB	214856	NANJING KING-FRIEND
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AB	078660	SANDOZ INC
LOVENOX	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AB	020164	SANOFI AVENTIS US