01 3ANDA REPOSITORY
02 3APOTEX INC
03 3AUROBINDO PHARMA
04 3AUROBINDO PHARMA LTD
05 6BARR
06 3CHARTWELL RX
07 3HERITAGE PHARMA
08 4HIKMA
09 3IMPAX LABS
10 7JANSSEN PHARMS
11 3MYLAN
12 6PHARMOBEDIENT
13 3RANBAXY
14 3SANDOZ
15 3SUN PHARM
16 3SUN PHARM INDS
17 6WATSON LABS
18 3YABAO PHARM
19 3ZYDUS PHARMS USA INC
01 21CAPSULE, EXTENDED RELEASE;ORAL
02 2SOLUTION;ORAL
03 9TABLET; ORAL
04 39TABLET;ORAL
01 31DISCN
02 31RX
03 9Blank
01 64GALANTAMINE HYDROBROMIDE
02 4RAZADYNE
03 3RAZADYNE ER
01 56No
02 6Yes
03 9Blank
RLD : No
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2009-09-15
Application Number : 77585
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 8MG BASE
Approval Date : 2009-09-15
Application Number : 77585
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : GALANTAMINE HYDROBROMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 12MG BASE
Approval Date : 2009-09-15
Application Number : 77585
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2001-02-28
Application Number : 21169
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2001-02-28
Application Number : 21169
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2001-02-28
Application Number : 21169
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : RAZADYNE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2001-06-22
Application Number : 21224
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE ER
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-04-01
Application Number : 21615
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE ER
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-04-01
Application Number : 21615
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RAZADYNE ER
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-04-01
Application Number : 21615
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
