Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080680
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLIC ACID FOLIC ACID 1MG TABLET;ORAL Prescription AA 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
12/23/1971 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080680.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2001 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1997 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-54 Labeling

Label is not available on this site.

01/19/1990 SUPPL-53 Labeling

Label is not available on this site.

11/19/1990 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

05/02/1988 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

05/02/1988 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

05/02/1988 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/28/1985 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/28/1985 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/28/1985 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/28/1985 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/16/1984 SUPPL-41 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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