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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202788

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SUBSYS (FENTANYL)
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 001
Approval Date: Jan 4, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 002
Approval Date: Jan 4, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 003
Approval Date: Jan 4, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 004
Approval Date: Jan 4, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 005
Approval Date: Jan 4, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 006
Approval Date: Aug 30, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SUBSYS (FENTANYL)
1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: SUBSYS
Dosage Form; Route of Administration: SPRAY; SUBLINGUAL
Strength: 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202788
Product Number: 007
Approval Date: Aug 30, 2012
Applicant Holder Full Name: BTCP PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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