Product Details for NDA 213876
ALKINDI SPRINKLE (HYDROCORTISONE)
0.5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
0.5MG
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 001
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALKINDI SPRINKLE (HYDROCORTISONE)
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 001
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
1MG
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 002
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALKINDI SPRINKLE (HYDROCORTISONE)
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 002
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 003
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALKINDI SPRINKLE (HYDROCORTISONE)
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N213876
Product Number: 003
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213876
Product Number: 004
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ALKINDI SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213876
Product Number: 004
Approval Date: Sep 29, 2020
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information