Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021211

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FOLLISTIM AQ (FOLLITROPIN ALFA/BETA)
300 IU/0.36ML Marketing Status: Prescription

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: FOLLISTIM AQ
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 IU/0.36ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021211
Product Number: 001
Approval Date: Mar 23, 2004
Applicant Holder Full Name: ORGANON USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOLLISTIM AQ (FOLLITROPIN ALFA/BETA)
600 IU/0.72ML Marketing Status: Prescription

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: FOLLISTIM AQ
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 600 IU/0.72ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021211
Product Number: 002
Approval Date: Mar 23, 2004
Applicant Holder Full Name: ORGANON USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOLLISTIM AQ (FOLLITROPIN ALFA/BETA)
900 IU/1.08ML Marketing Status: Prescription

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: FOLLISTIM AQ
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 900 IU/1.08ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021211
Product Number: 004
Approval Date: Feb 11, 2005
Applicant Holder Full Name: ORGANON USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOLLISTIM AQ (FOLLITROPIN ALFA/BETA)
150 IU/0.18ML Marketing Status: Discontinued

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: FOLLISTIM AQ
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 150 IU/0.18ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021211
Product Number: 003
Approval Date: Feb 11, 2004
Applicant Holder Full Name: ORGANON USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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