Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021148

Expand all

NORDITROPIN FLEXPRO (SOMATROPIN RECOMBINANT)
5MG/1.5ML Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN FLEXPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: BX
Application Number: N021148
Product Number: 008
Approval Date: Mar 1, 2010
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORDITROPIN FLEXPRO (SOMATROPIN RECOMBINANT)
10MG/1.5ML Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN FLEXPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: BX
Application Number: N021148
Product Number: 009
Approval Date: Mar 1, 2010
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORDITROPIN FLEXPRO (SOMATROPIN RECOMBINANT)
15MG/1.5ML Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN FLEXPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 010
Approval Date: Mar 1, 2010
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORDITROPIN FLEXPRO (SOMATROPIN RECOMBINANT)
30MG/3ML Marketing Status: Prescription

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN FLEXPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/3ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 011
Approval Date: Jan 23, 2015
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORDITROPIN (SOMATROPIN RECOMBINANT)
5MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 001
Approval Date: Jun 20, 2000
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN (SOMATROPIN RECOMBINANT)
10MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 002
Approval Date: Jun 20, 2000
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN (SOMATROPIN RECOMBINANT)
15MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 003
Approval Date: Jun 20, 2000
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN NORDIFLEX (SOMATROPIN RECOMBINANT)
5MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN NORDIFLEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 004
Approval Date: Oct 1, 2004
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN NORDIFLEX (SOMATROPIN RECOMBINANT)
10MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN NORDIFLEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 005
Approval Date: Oct 1, 2004
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN NORDIFLEX (SOMATROPIN RECOMBINANT)
15MG/1.5ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN NORDIFLEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/1.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 006
Approval Date: Oct 1, 2004
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORDITROPIN NORDIFLEX (SOMATROPIN RECOMBINANT)
30MG/3ML Marketing Status: Discontinued

Active Ingredient: SOMATROPIN RECOMBINANT
Proprietary Name: NORDITROPIN NORDIFLEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/3ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021148
Product Number: 007
Approval Date: Mar 10, 2009
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English