Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020378

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GONAL-F (FOLLITROPIN ALFA/BETA)
450 IU/VIAL Marketing Status: Prescription

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: GONAL-F
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 450 IU/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020378
Product Number: 005
Approval Date: Mar 26, 2004
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GONAL-F (FOLLITROPIN ALFA/BETA)
1,050 IU/VIAL Marketing Status: Prescription

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: GONAL-F
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 1,050 IU/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020378
Product Number: 004
Approval Date: Feb 28, 2001
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GONAL-F (FOLLITROPIN ALFA/BETA)
37.5 IU/VIAL Marketing Status: Discontinued

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: GONAL-F
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 37.5 IU/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020378
Product Number: 003
Approval Date: May 25, 2000
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

GONAL-F (FOLLITROPIN ALFA/BETA)
75 IU/VIAL Marketing Status: Discontinued

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: GONAL-F
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 75 IU/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020378
Product Number: 001
Approval Date: Sep 29, 1997
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

GONAL-F (FOLLITROPIN ALFA/BETA)
150 IU/VIAL Marketing Status: Discontinued

Active Ingredient: FOLLITROPIN ALFA/BETA
Proprietary Name: GONAL-F
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 150 IU/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020378
Product Number: 002
Approval Date: Sep 29, 1997
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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