Product Details for NDA 007337
PERCODAN (ASPIRIN; OXYCODONE HYDROCHLORIDE)
325MG;4.8355MG
Marketing Status: Prescription
325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;4.8355MG
Marketing Status: Prescription
Active Ingredient: ASPIRIN; OXYCODONE HYDROCHLORIDE
Proprietary Name: PERCODAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;4.8355MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N007337
Product Number: 007
Approval Date: Aug 5, 2005
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PERCODAN (ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE)
Proprietary Name: PERCODAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;4.8355MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N007337
Product Number: 007
Approval Date: Aug 5, 2005
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Proprietary Name: PERCODAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N007337
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PERCODAN-DEMI (ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE)
Proprietary Name: PERCODAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N007337
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Proprietary Name: PERCODAN-DEMI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N007337
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PERCODAN-DEMI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N007337
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information