Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213317
Company: XIROMED

Products on ANDA 213317

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEMMILY	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213317

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213317Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/13/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213317

GEMMILY

CAPSULE;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEMMILY	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	213317	XIROMED
MERZEE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	212706	WILSHIRE PHARMS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	213418	GLENMARK PHARMS LTD
TAYTULLA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	Yes	AB	204426	APIL