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`EXHIBIT C
`
`[Excerpted from:
`https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProces
`s/HowDrugsareDevelopedandApproved/ApprovalApplications/Abb
`reviatedNewDrugApplicationANDAGenerics/UCM293268.pdf]
`
`
`
`Case 1:18-cv-00303-RGA Document 64-3 Filed 11/14/18 Page 2 of 2 PageID #: 1497
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`
`
`Paragraph IV Patent Certifications
`October 22, 2018
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD/NDA
`
`
`Desloratadine and
`Pseudoephedrine Sulfate
`
`
`Extended-release
`Tablets
`
`Desloratadine and
`Pseudoephedrine Sulfate
`
`Extended-release
`Tablets
`
`
`Desmopressin Acetate
`
`
`Injection
`
`Desmopressin Acetate
`
`Nasal Spray
`
`Desmopressin Acetate
`
`Tablets
`
`Desogestrel; Ethinyl Estradiol
`Tablets
`
`Desonide
`
`Tablets
`
`Gel
`
`Desoximetasone
`
`Topical Spray
`
`
`Desvenlafaxine Succinate
`
`Desvenlafaxine Succinate
`
`Dexlansoprazole
`
`Dexlansoprazole
`
`Dexmedetomidine
`
`Dexmedetomidine*
`
`Dexmedetomidine
`
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`
`Extended-release
`Tablets
`Extended-release
`Tablets
`Delayed-release
`Capsules
`Delayed-release
`Capsules
`
`Injection
`
`Injection
`
`Injection
`
`
`Tablets
`
`Tablets
`
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`
`
`2.5 mg/120 mg
`
`
`5 mg/240 mg
`
`4 mcg/mL, 1 mL and
`10 mL vials
`
`0.01%
`
`0.15mg/ 0.02 mg
`and 0.01 mg
`
`0.05%
`
`0.25%
`
`
`50 mg and 100 mg
`
`Clarinex-D 24
`Hour
`21313
`Clarinex-D 24
`Hour
`21313
`DDAVP
`18938
`DDAVP
`17922
`0.1 mg and 0.2 mg DDAVP
`19955
`Mircette
`20713
`Desonate
`21844
`Topicort
`204141
`Pristiq
`21992
`Pristiq
`21992
`Dexilant
`22287
`Dexilant
`2287
`Precedex
`21038
`Precedex
`21038
`Precedex
`21038
`Focalin
`21278
`Focalin
`21278
`Focalin XR
`21802
`Focalin XR
`21802
`Focalin XR
`21802
`
`25 mg
`
`30 mg
`
`60 mg
`
`100 mcg/mL
`
`4 mcg/mL, 50 mL
`and 100 mL vials
`4 mcg/mL, 20 mL
`vials
`
`2.5 mg
`
`5 mg and 10 mg
`
`15 mg
`
`5 mg, 10 mg and
`20 mg
`
`30 mg
`
`Page 16
`
`DATE OF
`SUBMISSION
`
`
`6/1/2007
`
`
`6/21/2006
`
`
`
`
`
`
`
`
`
`12/1/2010
`
`12/18/2013
`
`
`2/29/2012
`
`5/8/2015
`
`11/30/2010
`
`8/25/2010
`
`4/8/2009
`
`12/26/2013
`
`9/30/2015
`
`
`7/27/2004
`
`5/27/2004
`
`5/14/2007
`
`3/30/2007
`
`12/15/2010
`
`