01 3AMLODIPINE BESYLATE
02 1GUAIFENESIN; HYDROCODONE BITARTRATE
01 1SOLUTION;ORAL
02 3TABLET;ORAL
01 1200MG/5ML;2.5MG/5ML
02 1EQ 10MG BASE
03 1EQ 2.5MG BASE
04 1EQ 5MG BASE
01 4DISCN
RLD : No
TE Code :
Sovereign Pharmaceuticals, LLC
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 2.5MG BASE
Approval Date : 2015-07-23
Application Number : 204900
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Sovereign Pharmaceuticals, LLC
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 5MG BASE
Approval Date : 2015-07-23
Application Number : 204900
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Sovereign Pharmaceuticals, LLC
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 10MG BASE
Approval Date : 2015-07-23
Application Number : 204900
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
GUAIFENESIN; HYDROCODONE BITARTRATE
Sovereign Pharmaceuticals, LLC
Dosage Form : SOLUTION; ORAL
Proprietary Name : OBREDON
Dosage Strength : 200MG/5ML;2.5MG/5ML
Approval Date : 2014-11-14
Application Number : 205474
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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