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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207724

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PROGESTERONE (PROGESTERONE)
100MG
Marketing Status: Prescription
Active Ingredient: PROGESTERONE
Proprietary Name: PROGESTERONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207724
Product Number: 001
Approval Date: Sep 7, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PROGESTERONE (PROGESTERONE)
200MG
Marketing Status: Prescription
Active Ingredient: PROGESTERONE
Proprietary Name: PROGESTERONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207724
Product Number: 002
Approval Date: Sep 7, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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