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03 Mar 2025
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GDUFA
DMF Review : Complete
Rev. Date : 2014-03-07
Pay. Date : 2013-07-15
DMF Number : 8682
Submission : 1990-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9655
Submission : 1992-04-28
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R0-CEP 2013-253 - Rev 00
Status : Expired
Issue Date : 2014-10-15
Type : Chemical
Substance Number : 1795
NDC Package Code : 57755-0004
Start Marketing Date : 2013-04-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 300MG;30MG
Packaging :
Approval Date : 1992-07-16
Application Number : 81250
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET;ORAL
Brand Name : ACETAMINOPHEN AND CODEINE...
Dosage Strength : 300MG;60MG
Packaging :
Approval Date : 1992-07-16
Application Number : 81249
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET;ORAL
Brand Name : PERPHENAZINE AND AMITRIPT...
Dosage Strength : 25MG;2MG
Packaging :
Approval Date : 1987-11-27
Application Number : 71063
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET;ORAL
Brand Name : PERPHENAZINE AND AMITRIPT...
Dosage Strength : 10MG;4MG
Packaging :
Approval Date : 1987-12-21
Application Number : 71862
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET;ORAL
Brand Name : PERPHENAZINE AND AMITRIPT...
Dosage Strength : 10MG;2MG
Packaging :
Approval Date : 1987-11-27
Application Number : 71062
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET;ORAL
Brand Name : PERPHENAZINE AND AMITRIPT...
Dosage Strength : 25MG;4MG
Packaging :
Approval Date : 1987-11-27
Application Number : 71064
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : BUTALBITAL, ASPIRIN AND C...
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1984-04-06
Application Number : 86398
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Brand Name : LONOX
Dosage Strength : 0.025MG;2.5MG
Packaging :
Approval Date : 1982-01-01
Application Number : 85311
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Brand Name : DIPHENOXYLATE HYDROCHLORI...
Dosage Strength : 0.025MG;2.5MG
Packaging :
Approval Date : 1982-01-01
Application Number : 86173
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : CARISOPRODOL
Dosage Strength : 350MG
Packaging :
Approval Date : 1989-04-13
Application Number : 81025
Regulatory Info : RX
Registration Country : USA
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;60MG
Approval Date : 1992-07-16
Application Number : 81249
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;30MG
Approval Date : 1992-07-16
Application Number : 81250
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET; ORAL
Proprietary Name : PERPHENAZINE AND AMITRIP...
Dosage Strength : 10MG;2MG
Approval Date : 1987-11-27
Application Number : 71062
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET; ORAL
Proprietary Name : PERPHENAZINE AND AMITRIP...
Dosage Strength : 25MG;2MG
Approval Date : 1987-11-27
Application Number : 71063
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET; ORAL
Proprietary Name : PERPHENAZINE AND AMITRIP...
Dosage Strength : 25MG;4MG
Approval Date : 1987-11-27
Application Number : 71064
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Dosage Form : TABLET; ORAL
Proprietary Name : PERPHENAZINE AND AMITRIP...
Dosage Strength : 10MG;4MG
Approval Date : 1987-12-21
Application Number : 71862
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ASPIRIN AND ...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 1984-04-06
Application Number : 86398
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : LONOX
Dosage Strength : 0.025MG;2.5MG
Approval Date : 1982-01-01
Application Number : 85311
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : DIPHENOXYLATE HYDROCHLOR...
Dosage Strength : 0.025MG;2.5MG
Approval Date : 1982-01-01
Application Number : 86173
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : CARISOPRODOL
Dosage Strength : 350MG
Approval Date : 1989-04-13
Application Number : 81025
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-03-13
City : Guilin
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-03-13
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-09-02
City : Guilin
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-09-02
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Guilin Pharmaceutical Co., Ltd...
Business Address : No.43, Qilidian Road Guilin ...
FEI Number : 3002807125
Country : China
Paid in : 2019
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