Details for New Drug Application (NDA): 203339
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NDA 203339 describes AMABELZ, which is a drug marketed by Lupin Ltd and is included in one NDA. Additional details are available on the AMABELZ profile page.
The generic ingredient in AMABELZ is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
The generic ingredient in AMABELZ is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 203339
| Tradename: | AMABELZ |
| Applicant: | Lupin Ltd |
| Ingredient: | estradiol; norethindrone acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG;0.1MG | ||||
| Approval Date: | Jun 20, 2016 | TE: | BX | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG | ||||
| Approval Date: | Jun 20, 2016 | TE: | BX | RLD: | No | ||||
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