GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39744
Submission : 2024-03-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39744
Submission : 2024-03-27
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : EZETIMIBE AND SIMVASTATIN
Dosage Form : TABLET; ORAL
Application Number : 202968
Country : US
Patented : No
Drug : EZETIMIBE AND SIMVASTATIN
Dosage Form : TABLET; ORAL
Application Number : 209222
Country : US
Patented : No
Drug : EZETIMIBE AND SIMVASTATIN
Dosage Form : TABLET; ORAL
Application Number : 208831
Country : US
Patented : No
Drug : PLENDIL
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 19834
Country : US
Patented : No
Drug : DERMATOP
Dosage Form : OINTMENT; TOPICAL
Application Number : 19568
Country : US
Patented : No
Drug : FELODIPINE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 200815
Country : US
Patented : No
Drug : DESOWEN
Dosage Form : LOTION; TOPICAL
Application Number : 72354
Country : US
Patented : No
Drug : DESOWEN
Dosage Form : CREAM; TOPICAL
Application Number : 19048
Country : US
Patented : No
Drug : AMCINONIDE
Dosage Form : OINTMENT; TOPICAL
Application Number : 76096
Country : US
Patented : No
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Drug : ADVIL CONGESTION RELIEF
Dosage Form : TABLET; ORAL
Application Number : 22565
Country : US
Patented : No
PROPYL GALLATE
Route : INTRAMUSCULAR
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.16
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 2
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.2
Potency Unit : MG/1ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 1
Potency Unit : MG/5ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 1.36
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.067
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.04
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.06
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
PROPYL GALLATE
Route : ORAL
CAS : 121-79-9
UNII : 8D4SNN7V92
Potency Amount : 0.04
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment, Tablet, Capsule, Gel, Solution
Grade : Oral, Topical
Category : API Stability Enhancers
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