GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33897
Submission : 2019-05-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33897
Submission : 2019-05-31
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Drug : NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Dosage Form : CAPSULE; ORAL
Application Number : 202250
Country : US
Patented : No
Drug : METFORMIN HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 79118
Country : US
Patented : No
Drug : CLINDAGEL
Dosage Form : GEL; TOPICAL
Application Number : 50782
Country : US
Patented : No
Drug : DIFFERIN
Dosage Form : LOTION; TOPICAL
Application Number : 22502
Country : US
Patented : Yes
Drug : PALIPERIDONE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 204452
Country : US
Patented : No
Drug : DIETHYLPROPION HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 91680
Country : US
Patented : No
Drug : DESONATE
Dosage Form : GEL; TOPICAL
Application Number : 21844
Country : US
Patented : No
Drug : SILDENAFIL CITRATE
Dosage Form : FOR SUSPENSION; ORAL
Application Number : 215708
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment, Suspension
Grade : Oral & Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Pharmacopoeia Ref : United States Pharmacopeia/Nat...
Technical Specs : Viscosity, cP (0.5 wt% at pH 7.5)- 4,000 - 11,000
Ingredient(s) : Carbomer Homopolymer Type A
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel
Grade : Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Pharmacopoeia Ref : United States Pharmacopeia/Nat...
Technical Specs : Viscosity, cP (0.2 wt% at pH 7.5) - 1,000 - 6,000 Viscosity, cP ...
Ingredient(s) : Carbomer Homopolymer Type A
Dosage Form : Cream / Lotion / Ointment, Emulsion, Suspension
Grade : Oral and Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer Homopolymer ...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Oral and Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF: Carbomer Homopolymer T...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Dosage Form : Cream / Lotion / Ointment, Emulsion, Suspension
Grade : Oral and Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer Homopolymer ...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Dosage Form : Cream / Lotion / Ointment, Emulsion, Suspension
Grade : Oral and Topical
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer 941
Technical Specs : Not Available
Ingredient(s) : Carbomer 941
Application : Controlled & Modified Release
Pharmacopoeia Ref : United States Pharmacopeia/Nat...
Technical Specs : Viscosity, cP (0.5 wt% at pH 7.5)- 4,000 - 11,000
Ingredient(s) : Carbomer Homopolymer Type A
Application : Controlled & Modified Release
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer Homopolymer ...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Application : Controlled & Modified Release
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF: Carbomer Homopolymer T...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Application : Controlled & Modified Release
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer Homopolymer ...
Technical Specs : Not Available
Ingredient(s) : Carbomer Homopolymer Type A
Application : Controlled & Modified Release
Excipient Details : It is widely used in oral solid, liquid dosage forms & topical formulations. It acts as excellent gel matrix former for controlling drug release in solid dosage forms.
Pharmacopoeia Ref : USP/NF : Carbomer 941
Technical Specs : Not Available
Ingredient(s) : Carbomer 941
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