Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090035
Company: CHARTWELL MOLECULAR

Products on ANDA 090035

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090035

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	091145	AIPING PHARM INC
FOLIC ACID	FOLIC ACID	1MG	TABLET;ORAL	Prescription	No	AA	040625	AMNEAL PHARM
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	211064	RISING
FOLIC ACID	FOLIC ACID	1MG	TABLET;ORAL	Prescription	Yes	AA	080680	WATSON LABS