Product Details for NDA 206627
HYSINGLA ER (HYDROCODONE BITARTRATE)
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
80MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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
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