17 Feb 2026
// PRESS RELEASE
16 Oct 2025
// PRESS RELEASE
26 Feb 2025
// PRESS RELEASE
Latest Content by PharmaCompass
KEY EXCIPIENTS
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01 2Calcium Carbonate Excipient
02 10Magnesium Hydroxide Excipient
03 4Mannitol
04 1Sodium Bicarbonate Excipient
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01 7Active
02 10Blank
01 17Blank
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01 17Blank
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01 17Blank
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01 17Blank
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01 112784-188
02 112784-192
03 112784-196
04 112784-198
05 112784-441
06 112784-448
07 112784-456
08 112784-458
09 112784-459
10 167417-243
11 7Blank
01 17Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21367
Submission : 2008-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39027
Submission : 2024-06-14
Status : Active
Type : II
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 : 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 : 20389
Submission : 2007-03-30
Status : Active
Type : IV
NDC Package Code : 12784-459
Start Marketing Date : 2022-09-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 12784-458
Start Marketing Date : 2022-05-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
NDC Package Code : 67417-243
Start Marketing Date : 2021-11-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (95kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
Spi Pharma is a supplier offers 9 products (APIs, Excipients or Intermediates).
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