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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219761
Company: ANNORA PHARMA

Products on ANDA 219761

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219761

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219761Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219761

DESOGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVERI	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	218933	AVION PHARMS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	219761	ANNORA PHARMA
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	075256	DURAMED PHARMS BARR
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207067	NAARI PTE
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	091234	NOVAST LABS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	076915	WATSON LABS
ENSKYCE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	201887	LUPIN LTD
ISIBLOOM	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	202789	XIROMED
KALLIGA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207081	AUROBINDO PHARMA

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