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FDA Drug Approval, A203593, DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
FDA Drug Approval, A203593, DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
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ANDA: 203593
Company: WATSON LABS INC
Drug Name: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Active Ingredients: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Strength: 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Dosage Form/Route: TABLET;ORAL
Action Date: 10/11/2016
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB
Company: WATSON LABS INC
Drug Name: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Active Ingredients: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Strength: 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Dosage Form/Route: TABLET;ORAL
Action Date: 10/11/2016
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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