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01 1ATHENA
02 1STRIDES PHARMA
03 3STRIDES PHARMA INTL
04 1ACCORD HLTHCARE
05 4ACTAVIS ELIZABETH
06 1ALKEM LABS LTD
07 2AMNEAL PHARMS
08 1APOTEX
09 1ASTA
10 1AUROBINDO PHARMA
11 4AUROBINDO PHARMA LTD
12 1CHARTWELL RX
13 4CIPHER PHARMS INC
14 1CSPC OUYI PHARM CO
15 3GRAVITI PHARMS
16 1IPCA LABS LTD
17 1IVAX SUB TEVA PHARMS
18 3JANSSEN PHARMS
19 1KOWA PHARMS
20 3LUPIN LTD
21 5MACLEODS PHARMS LTD
22 1MICRO LABS LTD INDIA
23 1MPP PHARMA
24 4MYLAN
25 1MYLAN PHARMS INC
26 1NORTHSTAR HLTHCARE
27 3PH HEALTH
28 1PLIVA
29 1PURACAP LABS BLU
30 3PURDUE PHARMA
31 1RISING
32 4RUBICON RESEARCH
33 1SENORES PHARMS
34 1SHIONOGI INC
35 1SPECGX LLC
36 6SUN PHARM
37 2SUN PHARM INDS INC
38 1SUN PHARM INDUSTRIES
39 1TEVA
40 1UNICHEM
41 3VALEANT PHARMS
42 1WATSON LABS
43 1ZYDUS PHARMS USA INC
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01 4CAPSULE, EXTENDED RELEASE;ORAL
02 1SOLUTION;ORAL
03 33TABLET, EXTENDED RELEASE;ORAL
04 1TABLET, ORALLY DISINTEGRATING;ORAL
05 44TABLET;ORAL
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01 54DISCN
02 29RX
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01 4CONZIP
02 1QDOLO
03 1RYBIX ODT
04 3RYZOLT
05 1SEGLENTIS
06 56TRAMADOL HYDROCHLORIDE
07 11TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
08 1ULTRACET
09 2ULTRAM
10 3ULTRAM ER
01 68No
02 15Yes
RLD : Yes
TE Code :
Brand Name : QDOLO
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/ML
Approval Date : 2020-09-01
Application Number : 214044
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG
Approval Date : 2009-11-13
Application Number : 78783
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 200MG
Approval Date : 2009-11-13
Application Number : 78783
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 300MG
Approval Date : 2011-09-20
Application Number : 78783
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : TRAMADOL HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 2011-11-28
Application Number : 202075
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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RLD : Yes
TE Code :
Brand Name : ULTRAM ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-09-08
Application Number : 21692
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ULTRAM ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2005-09-08
Application Number : 21692
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ULTRAM
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-03-03
Application Number : 20281
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ULTRAM
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-03-03
Application Number : 20281
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Brand Name : ULTRACET
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;37.5MG
Approval Date : 2001-08-15
Application Number : 21123
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
