Drugs@FDA: FDA Approved Drug Products

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

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 202522 EXELA PHARMA SCS LLC
FOLIC ACID FOLIC ACID 5MG/ML INJECTABLE;INJECTION Prescription No AP 089202 FRESENIUS KABI USA

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