Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019781

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PROMETRIUM (PROGESTERONE)
100MG
Marketing Status: Prescription

Active Ingredient: PROGESTERONE
Proprietary Name: PROMETRIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019781
Product Number: 001
Approval Date: May 14, 1998
Applicant Holder Full Name: VIRTUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROMETRIUM (PROGESTERONE)
200MG
Marketing Status: Prescription

Active Ingredient: PROGESTERONE
Proprietary Name: PROMETRIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019781
Product Number: 002
Approval Date: Oct 15, 1999
Applicant Holder Full Name: VIRTUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROMETRIUM (PROGESTERONE)
300MG
Marketing Status: Discontinued

Active Ingredient: PROGESTERONE
Proprietary Name: PROMETRIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019781
Product Number: 003
Approval Date: Oct 15, 1999
Applicant Holder Full Name: VIRTUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information