GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41204
Submission : 2025-01-15
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41812
Submission : 2025-07-25
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV

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Mannitol, For Use In The Manufacture Of Parenter...
Certificate Number : CEP 2005-019 - Rev 04
Status : Valid
Issue Date : 2025-11-17
Type : Chemical
Substance Number : 559

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Certificate Number : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

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Certificate Number : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] FINISHED DOSAGE FORMULATIONS
MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 32.58
Potency Unit : MG

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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.78
Potency Unit : MG

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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.76
Potency Unit : MG

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MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 37.11
Potency Unit : MG

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MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 97.69
Potency Unit : MG

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MANNITOL
Route : BUCCAL/SUBLINGUAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 52.5
Potency Unit : MG

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MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 2.5
Potency Unit : %

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MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 30
Potency Unit : %

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Product Web Link
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MANNITOL
Route : IM - IV - SC
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA

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Product Web Link
Virtual Booth
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MANNITOL
Route : IM - SC
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA

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Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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