DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076225
The generic ingredient in ERRIN is norethindrone. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 076225
Tradename: | ERRIN |
Applicant: | Mayne Pharma |
Ingredient: | norethindrone |
Patents: | 0 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076225
Ingredient-type | Progesterone Congeners |
Medical Subject Heading (MeSH) Categories for 076225
Suppliers and Packaging for NDA: 076225
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERRIN | norethindrone | TABLET;ORAL-28 | 076225 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0344 | N | 0555-0344-58 |
ERRIN | norethindrone | TABLET;ORAL-28 | 076225 | ANDA | Mayne Pharma Inc. | 51862-100 | N | 51862-100-06 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
Approval Date: | Oct 21, 2002 | TE: | AB2 | RLD: | No |
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