GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2016-283 - Rev 01
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Status : Valid
Certificate Number : R1-CEP 2009-392 - Rev 01
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Status : Valid
Certificate Number : CEP 2006-085 - Rev 04
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2016-283 - Rev 01
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Certificate Number : R1-CEP 2009-392 - Rev 01
Status : Valid
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Macrogols, Types 3350 and 4000
Certificate Number : CEP 2006-085 - Rev 04
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
FINISHED DOSAGE FORMULATIONS
Drug : CLARITHROMYCIN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 65154
Country : US
Patented : No
Drug : VALGANCICLOVIR HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Application Number : 200790
Country : US
Patented : No
Drug : IBUPROFEN
Dosage Form : TABLET; ORAL
Application Number : 78329
Country : US
Patented : No
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Drug : OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form : TABLET; ORAL
Application Number : 209281
Country : US
Patented : No
Drug : QUETIAPINE FUMARATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 206252
Country : US
Patented : No
Drug : TROSPIUM CHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 91289
Country : US
Patented : No
Drug : OLMESARTAN MEDOXOMIL
Dosage Form : TABLET; ORAL
Application Number : 203012
Country : US
Patented : No
Drug : QUETIAPINE FUMARATE
Dosage Form : TABLET; ORAL
Application Number : 201504
Country : US
Patented : No
Drug : LACOSAMIDE
Dosage Form : SOLUTION; ORAL
Application Number : 209301
Country : US
Patented : No
Drug : SIMVASTATIN
Dosage Form : TABLET; ORAL
Application Number : 76052
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Brand Name : PEG/Macrogol 4000
Application : Parenteral
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 4000
MARKET PLACE
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