Details for New Drug Application (NDA): 212706
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The generic ingredient in MERZEE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 212706
Tradename: | MERZEE |
Applicant: | Wilshire Pharms Inc |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 212706
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MERZEE | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 212706 | ANDA | Lupin Pharmaceuticals, Inc. | 43386-371 | 43386-371-32 | 1 BLISTER PACK in 1 CARTON (43386-371-32) / 1 KIT in 1 BLISTER PACK |
MERZEE | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 212706 | ANDA | Slayback Pharma LLC | 71225-130 | 71225-130-01 | 1 BLISTER PACK in 1 CARTON (71225-130-01) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.02MG;1MG | ||||
Approval Date: | Dec 18, 2020 | TE: | AB | RLD: | No |
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