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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204704
Company: XIROMED

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;1MG TABLET;ORAL-28 Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/09/2016 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
08/09/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.05MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;1MG TABLET;ORAL-28 Prescription No AB 204704 XIROMED
MALMOREDE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;1MG TABLET;ORAL-28 Prescription No AB 209547 NOVAST LABS
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