01 5APOMORPHINE HYDROCHLORIDE
02 4ESLICARBAZEPINE ACETATE
03 1ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
04 1GLYCOPYRROLATE
05 1RELUGOLIX
01 2SUMITOMO PHARMA
02 10SUMITOMO PHARMA AM
01 5FILM;SUBLINGUAL
02 1SOLUTION;INHALATION
03 6TABLET;ORAL
01 110MG
02 1120MG
03 115MG
04 11MG;0.5MG;40MG
05 1200MG
06 120MG
07 125MCG/ML
08 125MG
09 130MG
10 1400MG
11 1600MG
12 1800MG
01 12USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : FILM;SUBLINGUAL
Brand Name : KYNMOBI
Dosage Strength : 10MG
Packaging :
Approval Date : 2020-05-21
Application Number : 210875
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : FILM;SUBLINGUAL
Brand Name : KYNMOBI
Dosage Strength : 15MG
Packaging :
Approval Date : 2020-05-21
Application Number : 210875
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : FILM;SUBLINGUAL
Brand Name : KYNMOBI
Dosage Strength : 20MG
Packaging :
Approval Date : 2020-05-21
Application Number : 210875
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : FILM;SUBLINGUAL
Brand Name : KYNMOBI
Dosage Strength : 25MG
Packaging :
Approval Date : 2020-05-21
Application Number : 210875
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : FILM;SUBLINGUAL
Brand Name : KYNMOBI
Dosage Strength : 30MG
Packaging :
Approval Date : 2020-05-21
Application Number : 210875
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : APTIOM
Dosage Strength : 200MG
Packaging :
Approval Date : 2013-11-08
Application Number : 22416
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : APTIOM
Dosage Strength : 400MG
Packaging :
Approval Date : 2013-11-08
Application Number : 22416
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : APTIOM
Dosage Strength : 600MG
Packaging :
Approval Date : 2013-11-08
Application Number : 22416
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : APTIOM
Dosage Strength : 800MG
Packaging :
Approval Date : 2013-11-08
Application Number : 22416
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Dosage Form : TABLET;ORAL
Brand Name : MYFEMBREE
Dosage Strength : 1MG;0.5MG;40MG
Packaging :
Approval Date : 2021-05-26
Application Number : 214846
Regulatory Info : RX
Registration Country : USA
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