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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203594
Company: WATSON LABS INC

Products on ANDA 203594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2016	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203594Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203594Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2017	SUPPL-5	Labeling-Proprietary Name Change		Label is not available on this site.

Labels for ANDA 203594

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203594Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 203594

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

TABLET;ORAL; 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	203594	WATSON LABS INC
SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	Yes	AB	022574	BAYER HLTHCARE
TYDEMY	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	205948	LUPIN LTD

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