Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213876

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ALKINDI SPRINKLE (HYDROCORTISONE)
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)
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)
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)
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