Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080680
Company: WATSON LABS

Products on ANDA 080680

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLIC ACID	FOLIC ACID	1MG	TABLET;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080680

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.

Therapeutic Equivalents for ANDA 080680

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	040796	LEADING
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	Yes	AA	080680	WATSON LABS