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Details for New Drug Application (NDA): 076225
NDA 076225 describes ERRIN, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the ERRIN profile page.
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.
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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