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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210875

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KYNMOBI (APOMORPHINE HYDROCHLORIDE)
10MG
Marketing Status: Discontinued
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: KYNMOBI
Dosage Form; Route of Administration: FILM; SUBLINGUAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210875
Product Number: 001
Approval Date: May 21, 2020
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KYNMOBI (APOMORPHINE HYDROCHLORIDE)
15MG
Marketing Status: Discontinued
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: KYNMOBI
Dosage Form; Route of Administration: FILM; SUBLINGUAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210875
Product Number: 002
Approval Date: May 21, 2020
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KYNMOBI (APOMORPHINE HYDROCHLORIDE)
20MG
Marketing Status: Discontinued
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: KYNMOBI
Dosage Form; Route of Administration: FILM; SUBLINGUAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210875
Product Number: 003
Approval Date: May 21, 2020
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KYNMOBI (APOMORPHINE HYDROCHLORIDE)
25MG
Marketing Status: Discontinued
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: KYNMOBI
Dosage Form; Route of Administration: FILM; SUBLINGUAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210875
Product Number: 004
Approval Date: May 21, 2020
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KYNMOBI (APOMORPHINE HYDROCHLORIDE)
30MG
Marketing Status: Discontinued
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: KYNMOBI
Dosage Form; Route of Administration: FILM; SUBLINGUAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210875
Product Number: 005
Approval Date: May 21, 2020
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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