Details for New Drug Application (NDA): 090454
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The generic ingredient in HEATHER is norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 090454
Tradename: | HEATHER |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | norethindrone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090454
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HEATHER | norethindrone | TABLET;ORAL-28 | 090454 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-303 | 68462-303-29 | 3 BLISTER PACK in 1 CARTON (68462-303-29) / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
Approval Date: | Apr 23, 2010 | TE: | AB1 | RLD: | No |
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