Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080600
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/31/1972 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080600.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/17/2000 SUPPL-31 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/13/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/13/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-27 Labeling

Label is not available on this site.

12/10/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/19/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/24/1995 SUPPL-23 Labeling

Label is not available on this site.

07/29/1994 SUPPL-22 Labeling

Label is not available on this site.

07/29/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/29/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/28/1993 SUPPL-19 Labeling

Label is not available on this site.

07/17/1989 SUPPL-14 Labeling

Label is not available on this site.

10/01/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/24/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/31/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/17/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

FOLIC ACID

TABLET;ORAL; 1MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 040625 AMNEAL PHARM
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 211064 ATHEM
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 202437 CADILA PHARMS LTD
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 090035 CHARTWELL MOLECULAR
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 080600 HIKMA PHARMS
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 040796 LEADING PHARMA LLC
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 204418 NUVO PHARMS INC
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 091145 QINGDAO BAHEAL PHARM
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 040756 VINTAGE
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription No AA 080680 WATSON LABS

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