Product Details for NDA 202880
ZOHYDRO ER (HYDROCODONE BITARTRATE)
10MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
40MG
Marketing Status: Discontinued
50MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 001
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOHYDRO ER (HYDROCODONE BITARTRATE)
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 001
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 002
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOHYDRO ER (HYDROCODONE BITARTRATE)
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 002
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 003
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOHYDRO ER (HYDROCODONE BITARTRATE)
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 003
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 004
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOHYDRO ER (HYDROCODONE BITARTRATE)
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 004
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 005
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOHYDRO ER (HYDROCODONE BITARTRATE)
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 005
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 006
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZOHYDRO ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202880
Product Number: 006
Approval Date: Oct 25, 2013
Applicant Holder Full Name: RECRO GAINESVILLE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information