Details for New Drug Application (NDA): 203339
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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 |
Pharmacology for NDA: 203339
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 203339
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMABELZ | estradiol; norethindrone acetate | TABLET;ORAL | 203339 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-829 | 68180-829-73 | 3 POUCH in 1 CARTON (68180-829-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK |
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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