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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203593
Company: WATSON LABS INC

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;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription AB No No

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 STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203593Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203593Orig1s000ltr.pdf

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/2016/203593Orig1s000lbl.pdf

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

TABLET;ORAL; 3MG,N/A;0.02MG,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
BEYAZ DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription Yes AB 022532 BAYER HLTHCARE
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 205947 LUPIN LTD
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG TABLET;ORAL Prescription No AB 203593 WATSON LABS INC
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