Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020280

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GENOTROPIN (SOMATROPIN RECOMBINANT)
5.8MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5.8MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N020280
Product Number: 006
Approval Date: Aug 24, 1995
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN (SOMATROPIN RECOMBINANT)
13.8MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 13.8MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020280
Product Number: 007
Approval Date: Oct 23, 1996
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
0.2MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 001
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
0.4MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.4MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 002
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
0.6MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.6MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 003
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
0.8MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.8MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 005
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 008
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1.2MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 009
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1.4MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.4MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 010
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1.6MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.6MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 011
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1.8MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.8MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 012
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
2MG/VIAL Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020280
Product Number: 013
Approval Date: Jan 27, 1998
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

GENOTROPIN PRESERVATIVE FREE (SOMATROPIN RECOMBINANT)
1.5MG/VIAL Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.5MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020280
Product Number: 004
Approval Date: Aug 24, 1995
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

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