GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37885
Submission : 2022-12-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14272
Submission : 1999-06-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7507
Submission : 1988-06-02
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27522
Submission : 2013-09-09
Status : Inactive
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : METHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 211796
Country : US
Patented : No
Drug : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 206703
Country : US
Patented : No
Drug : POSACONAZOLE
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 214476
Country : US
Patented : No
DEXMETHYLPHENIDATE HYDROCHLORIDE
Drug : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 79108
Country : US
Patented : No
DEXMETHYLPHENIDATE HYDROCHLORIDE
Drug : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 203614
Country : US
Patented : No
Drug : METHYLPHENIDATE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 91695
Country : US
Patented : No
Drug : DIETHYLPROPION HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 91680
Country : US
Patented : No
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Drug : DELSTRIGO
Dosage Form : TABLET; ORAL
Application Number : 210807
Country : US
Patented : Yes
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 44.6
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 66.78
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 24.29
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 560
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 50.4
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 325
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
HYPROMELLOSE ACETATE SUCCINATE
Route : ORAL
CAS : 71138971
UNII : NA
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Controlled & Modified Release
Pharmacopoeia Ref : Complies with relevant Europea...
Technical Specs : Water content – less than 6%; Size #0
Ingredient(s) : HPMC AS
Application : Vegetarian Capsules
Pharmacopoeia Ref : Complies with relevant Europea...
Technical Specs : Water content – less than 6%; Size #0
Ingredient(s) : HPMC AS
Application : Coating Systems & Additives
Excipient Details : Enteric Coating
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hypromellose Acetate Succinate
Application : Solubilizers
Excipient Details : Solubility enhancement, Spray-Dried Dispersion (SDD), Hot Melt Extrusion (HME)
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl methylcellulose acetate succinate
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18 Apr 2020