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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharms Intl | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS | |||
Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR | ||||
Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | ||||
Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | ||||
Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS | |||
Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-001 | Nov 19, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES | ||||
Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-002 | Nov 19, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |