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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 017031


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NDA 017031 describes OPILL, which is a drug marketed by Laboratoire Hra and is included in one NDA. It is available from one supplier. Additional details are available on the OPILL profile page.

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:OTCDosage:TABLET;ORALStrength0.075MG
Approval Date:Approved Prior to Jan 1, 1982TE: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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