Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206627

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HYSINGLA ER (HYDROCODONE BITARTRATE)
20MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N206627
Product Number: 001
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
30MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 002
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
40MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 003
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
60MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 004
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
80MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 005
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
100MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 006
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information

HYSINGLA ER (HYDROCODONE BITARTRATE)
120MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYSINGLA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206627
Product Number: 007
Approval Date: Nov 20, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information