Product Details for NDA 018662
ACCUTANE (ISOTRETINOIN)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOTRETINOIN
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018662
Product Number: 002
Approval Date: May 7, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ACCUTANE (ISOTRETINOIN)
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018662
Product Number: 002
Approval Date: May 7, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOTRETINOIN
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018662
Product Number: 004
Approval Date: Mar 28, 1983
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ACCUTANE (ISOTRETINOIN)
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018662
Product Number: 004
Approval Date: Mar 28, 1983
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOTRETINOIN
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG **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: N018662
Product Number: 003
Approval Date: May 7, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ACCUTANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG **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: N018662
Product Number: 003
Approval Date: May 7, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information