GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2001-114 - Rev 04
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436
Status : Valid
NDC Package Code : 50516-005
Start Marketing Date : 2021-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3298
Submission : 1978-09-07
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R1-CEP 2001-113 - Rev 02
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435
Status : Valid
FINISHED DOSAGE FORMULATIONS
Drug : LEXAPRO
Dosage Form : SOLUTION; ORAL
Application Number : 21365
Country : US
Patented : No
Drug : CARAFATE
Dosage Form : SUSPENSION; ORAL
Application Number : 19183
Country : US
Patented : No
Drug : DEPAKENE
Dosage Form : SYRUP; ORAL
Application Number : 18082
Country : US
Patented : No
Drug : DEPAKENE
Dosage Form : CAPSULE; ORAL
Application Number : 18081
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : SOLUTION; ORAL
Application Number : 65054
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : CAPSULE; ORAL
Application Number : 65044
Country : US
Patented : No
Drug : VERSACLOZ
Dosage Form : SUSPENSION; ORAL
Application Number : 203479
Country : US
Patented : Yes
Drug : ARISTOSPAN
Dosage Form : INJECTABLE; INJECTION
Application Number : 16466
Country : US
Patented : No
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Drug : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : SOLUTION; ORAL
Application Number : 40387
Country : US
Patented : No
Drug : TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage Form : ELIXIR; ORAL
Application Number : 40251
Country : US
Patented : No
SORBITOL
Route : BUCCAL
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 257
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : DENTAL
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRA-ARTICULAR
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRALESIONAL
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 45
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAMUSCULAR
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRASYNOVIAL
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 84.83
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 22.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 5.43
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : INTRAVENOUS
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 48
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITOL
Route : IV(INFUSION)
CAS : 50-70-4
UNII : 506T60A25R
Potency Amount : 4.7
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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REF. STANDARDS & IMPURITIES
CAS Number : 50-70-4
Quantity Per Vial : 125
Sale Unit : mg
Price : $225.00
Details : Material Origin- Plant - Synthetic; USMCA- No...
Monograph :
Storage :
Code/Batch No : Catalog #1617000 / R084Y0