Pfanstiehl

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33548

Submission : 2019-02-28

Status : Active

Type : II

02

Ammonium Lactate

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12612

Submission : 1997-08-05

Status : Active

Type : II

03

Methotrexate, High Purity Low Endoto...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39988

Submission : 2024-06-05

Status : Active

Type : II

04

Podophyllotoxin (p-126)

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25758

Submission : 2012-02-03

Status : Active

Type : II

05

Sodium Dl-lactate Solution 60%, Usp ...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7658

Submission : 1988-09-06

Status : Active

Type : II

06

Sodium Gluconate, Usp (s-108)

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2021-09-14

Pay. Date : 2021-09-09

DMF Number : 9147

Submission : 1991-05-31

Status : Active

Type : II

07

Streptozotocin (s-119)

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2614

Submission : 1976-02-17

Status : Active

Type : II

08

D-mannose, High Purity, Low Endotoxi...

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40291

Submission : 2024-07-31

Status : Active

Type : II

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