Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075840
Company: DURAMED PHARMS BARR

Products on ANDA 075840

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-21	Prescription	AB	No	No
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075840

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75840.ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-32	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/21/2022	SUPPL-31	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/21/2022	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/19/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
11/08/2002	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075840

CRYSELLE

TABLET;ORAL-21; 0.03MG;0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-21	Prescription	No	AB	075840	DURAMED PHARMS BARR

TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075840	DURAMED PHARMS BARR
ELINEST	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	091105	NOVAST LABS LTD
LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075288	DR REDDYS LABS SA
TURQOZ	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	202980	LUPIN LTD