GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28713
Submission : 2014-10-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-378 - Rev 00
Issue Date : 2018-08-17
Type : Chemical
Substance Number : 1671
Status : Valid
Certificate Number : R1-CEP 2001-403 - Rev 01
Issue Date : 2009-08-28
Type : TSE
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 2008-014 - Rev 01
Issue Date : 2016-08-31
Type : Chemical
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 1999-012 - Rev 03
Issue Date : 2011-01-07
Type : Chemical
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 2001-338 - Rev 01
Issue Date : 2009-08-31
Type : TSE
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 2001-082 - Rev 02
Issue Date : 2015-07-10
Type : TSE
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 2001-012 - Rev 01
Issue Date : 2008-05-16
Type : TSE
Substance Number : 496
Status : Valid
Certificate Number : R1-CEP 2000-279 - Rev 00
Issue Date : 2006-04-02
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2001-074 - Rev 01
Issue Date : 2013-04-23
Type : TSE
Substance Number : 496
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28713
Submission : 2014-10-03
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : ADMELOG SOLOSTAR
Dosage Form : SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Application Number : 209196
Country : US
Patented : No
Drug : ADMELOG
Dosage Form : SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Application Number : 209196
Country : US
Patented : No
Drug : LANTUS SOLOSTAR
Dosage Form : INJECTABLE; INJECTION
Application Number : 21081
Country : US
Patented : No
Drug : LANTUS
Dosage Form : INJECTABLE; INJECTION
Application Number : 21081
Country : US
Patented : No
Drug : HECTOROL
Dosage Form : CAPSULE; ORAL
Application Number : 20862
Country : US
Patented : No
Drug : CELEXA
Dosage Form : TABLET; ORAL
Application Number : 20822
Country : US
Patented : No
Drug : CRINONE
Dosage Form : GEL; VAGINAL
Application Number : 20701
Country : US
Patented : No
Drug : ANDRODERM
Dosage Form : FILM, EXTENDED RELEASE; TRANSDERMAL
Application Number : 20489
Country : US
Patented : No
Drug : CARAFATE
Dosage Form : SUSPENSION; ORAL
Application Number : 19183
Country : US
Patented : No
Drug : GELNIQUE
Dosage Form : GEL; TRANSDERMAL
Application Number : 22204
Country : US
Patented : Yes
EXCIPIENTS BY APPLICATIONS
Brand Name : Glycerol Multi-Compendial
Application : Parenteral
Excipient Details : A & C's Glycerol multi-compendial is an excipient that meets USP-NF, EP and BP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Glycerol Excipient
Application : Parenteral
Excipient Details : A & C's Glycerol is an excipient which meets the USP monograph.
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