Details for New Drug Application (NDA): 017031
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The generic ingredient in OPILL is norgestrel. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the norgestrel profile page.
Summary for 017031
Tradename: | OPILL |
Applicant: | Laboratoire Hra |
Ingredient: | norgestrel |
Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 017031
Generic Entry Date for 017031*:
Constraining patent/regulatory exclusivity:
RX TO OTC SWITCH OR OTC USE Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Medical Subject Heading (MeSH) Categories for 017031
Suppliers and Packaging for NDA: 017031
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OPILL | norgestrel | TABLET;ORAL | 017031 | NDA | L. Perrigo Company | 0113-8101 | 0113-8101-01 | 1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK |
OPILL | norgestrel | TABLET;ORAL | 017031 | NDA | L. Perrigo Company | 0113-8101 | 0113-8101-03 | 3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 0.075MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 13, 2026 | ||||||||
Regulatory Exclusivity Use: | RX TO OTC SWITCH OR OTC USE |
Expired US Patents for NDA 017031
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Laboratoire Hra | OPILL | norgestrel | TABLET;ORAL | 017031-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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