Mestranol; norethindrone - Generic Drug Details
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What are the generic sources for mestranol; norethindrone and what is the scope of freedom to operate?
Mestranol; norethindrone
is the generic ingredient in fourteen branded drugs marketed by Actavis Labs Ut Inc, Heritage Pharma, Watson Labs, Gd Searle Llc, Ortho Mcneil Pharm, and Ortho Mcneil Janssen, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.Summary for mestranol; norethindrone
| US Patents: | 0 |
| Tradenames: | 14 |
| Applicants: | 6 |
| NDAs: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Patent Applications: | 15 |
| DailyMed Link: | mestranol; norethindrone at DailyMed |
US Patents and Regulatory Information for mestranol; norethindrone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ortho Mcneil Janssen | ORTHO-NOVUM 1/50 28 | mestranol; norethindrone | TABLET;ORAL-28 | 016709-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ortho Mcneil Pharm | ORTHO-NOVUM 2-21 | mestranol; norethindrone | TABLET;ORAL-21 | 012728-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | NORETHINDRONE AND MESTRANOL | mestranol; norethindrone | TABLET;ORAL-28 | 070759-001 | Jul 1, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gd Searle Llc | NORINYL 1+80 28-DAY | mestranol; norethindrone | TABLET;ORAL-28 | 016725-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ortho Mcneil Pharm | ORTHO-NOVUM 10-21 | mestranol; norethindrone | TABLET;ORAL-21 | 012728-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heritage Pharma | NORETHIN 1/50M-21 | mestranol; norethindrone | TABLET;ORAL-21 | 071539-001 | Apr 12, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
