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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
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Hisamitsu Pharm Co | SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029-001 | Feb 20, 2008 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
Hisamitsu Pharm Co | SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029-002 | Nov 5, 2012 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE | |||
Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM | |||
Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2 | |||
Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER | |||
Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |