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 : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24380
Submission : 2011-02-22
Status : Inactive
Type : IV

NDC Package Code : 42533-114
Start Marketing Date : 2009-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24380
Submission : 2011-02-22
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 42533-114
Start Marketing Date : 2009-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
Drug : BORTEZOMIB
Dosage Form : POWDER; INTRAVENOUS
Application Number : 206927
Country : US
Patented : No
Drug : URSODIOL
Dosage Form : TABLET; ORAL
Application Number : 213504
Country : US
Patented : No
Drug : OTIPRIO
Dosage Form : INJECTABLE, SUSPENSION; OTIC
Application Number : 207986
Country : US
Patented : Yes

CLINDAMYCIN PHOSPHATE; TRETINOIN
Drug : VELTIN
Dosage Form : GEL; TOPICAL
Application Number : 50803
Country : US
Patented : No

Drug : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE; INJECTION
Application Number : 90099
Country : US
Patented : No

Drug : FOSPHENYTOIN SODIUM
Dosage Form : INJECTABLE; INJECTION
Application Number : 78277
Country : US
Patented : No

Drug : TIMOPTIC-XE
Dosage Form : SOLUTION, GEL FORMING/DROPS; OPHTHALMIC
Application Number : 20330
Country : US
Patented : No

Drug : LEUKINE
Dosage Form : VIAL
Application Number : 103362
Country : US
Patented : No

Drug : ISOVUE-370
Dosage Form : INJECTABLE; INJECTION
Application Number : 18735
Country : US
Patented : No

Drug : ISOVUE-300
Dosage Form : INJECTABLE; INJECTION
Application Number : 18735
Country : US
Patented : No

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EXCIPIENTS BY APPLICATIONS
MARKET PLACE
REF. STANDARDS & IMPURITIES