Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075288

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LOW-OGESTREL-28 (ETHINYL ESTRADIOL; NORGESTREL)
0.03MG;0.3MG
Marketing Status: Prescription

Active Ingredient: ETHINYL ESTRADIOL; NORGESTREL
Proprietary Name: LOW-OGESTREL-28
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.03MG;0.3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075288
Product Number: 002
Approval Date: Jul 28, 1999
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information

LOW-OGESTREL-21 (ETHINYL ESTRADIOL; NORGESTREL)
0.03MG;0.3MG
Marketing Status: Discontinued

Active Ingredient: ETHINYL ESTRADIOL; NORGESTREL
Proprietary Name: LOW-OGESTREL-21
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.03MG;0.3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A075288
Product Number: 001
Approval Date: Jul 28, 1999
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Discontinued
Patent and Exclusivity Information