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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 000552
Company: ASPEN GLOBAL INC

Products on NDA 000552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN LOCK FLUSH	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 000552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/1939	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2024	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/000552s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/000552Orig1s026ltr.pdf
08/02/1990	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/05/1988	SUPPL-23	Labeling		Label is not available on this site.
12/09/1987	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
01/06/1987	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/28/1986	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/1986	SUPPL-18	Efficacy-New Dosing Regimen		Label is not available on this site.
05/13/1985	SUPPL-17	Labeling		Label is not available on this site.
11/28/1980	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/28/1980	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/24/1981	SUPPL-13	Labeling		Label is not available on this site.
01/25/1978	SUPPL-12	Labeling		Label is not available on this site.
06/08/1981	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1978	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1975	SUPPL-8	Unspecified		Label is not available on this site.
07/28/1975	SUPPL-7	Unspecified		Label is not available on this site.

Labels for NDA 000552

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2024	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/000552s026lbl.pdf

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