Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089202
Company: FRESENIUS KABI USA

Products on ANDA 089202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLIC ACID	FOLIC ACID	5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1986	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089202.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2006	SUPPL-20	Labeling		Label is not available on this site.
03/21/2006	SUPPL-15	Labeling		Label is not available on this site.
12/05/2002	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
01/20/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/06/1990	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/08/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/08/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/08/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/08/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089202

FOLIC ACID

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOLIC ACID	FOLIC ACID	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	089202	FRESENIUS KABI USA
FOLIC ACID	FOLIC ACID	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202522	XGEN PHARMS