Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201510

PIRMELLA 7/7/7 (ETHINYL ESTRADIOL; NORETHINDRONE)
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: PIRMELLA 7/7/7
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201510
Product Number: 001
Approval Date: Apr 24, 2013
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
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