Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020860
Company: BAYER HLTHCARE

Products on NDA 020860

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVLITE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL-21	Discontinued	None	Yes	No
LEVLITE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL-28	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020860

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20860LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20860.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/17/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.