Details for New Drug Application (NDA): 208587
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The generic ingredient in ENDARI is l-glutamine. There are forty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the l-glutamine profile page.
Summary for 208587
Tradename: | ENDARI |
Applicant: | Emmaus Medcl |
Ingredient: | l-glutamine |
Patents: | 0 |
Suppliers and Packaging for NDA: 208587
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENDARI | l-glutamine | FOR SOLUTION;ORAL | 208587 | NDA | Emmaus Medical, Inc. | 42457-420 | 42457-420-60 | 60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 5GM/PACKET | ||||
Approval Date: | Jul 7, 2017 | TE: | AA | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jul 7, 2024 | ||||||||
Regulatory Exclusivity Use: | TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER. |
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