Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204633

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ACITRETIN (ACITRETIN)
10MG
Marketing Status: Prescription

Active Ingredient: ACITRETIN
Proprietary Name: ACITRETIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204633
Product Number: 001
Approval Date: May 22, 2015
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACITRETIN (ACITRETIN)
17.5MG
Marketing Status: Prescription

Active Ingredient: ACITRETIN
Proprietary Name: ACITRETIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 17.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204633
Product Number: 002
Approval Date: May 22, 2015
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACITRETIN (ACITRETIN)
22.5MG
Marketing Status: Prescription

Active Ingredient: ACITRETIN
Proprietary Name: ACITRETIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 22.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204633
Product Number: 003
Approval Date: May 22, 2015
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACITRETIN (ACITRETIN)
25MG
Marketing Status: Prescription

Active Ingredient: ACITRETIN
Proprietary Name: ACITRETIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204633
Product Number: 004
Approval Date: May 22, 2015
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information