Details for New Drug Application (NDA): 212706
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NDA 212706 describes MERZEE, which is a drug marketed by Wilshire Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the MERZEE profile page.
The generic ingredient in MERZEE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in MERZEE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six 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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