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01 1ATHENA
02 4STRIDES PHARMA
03 1ACCORD HLTHCARE
04 4ACTAVIS ELIZABETH
05 1ALKEM LABS LTD
06 2AMNEAL PHARMS
07 1APOTEX
08 1ASTA
09 1AUROBINDO PHARMA
10 4AUROBINDO PHARMA LTD
11 1CHARTWELL RX
12 4CIPHER PHARMS INC
13 1CSPC OUYI PHARM CO
14 3ENDO OPERATIONS
15 3GRAVITI PHARMS
16 1IPCA LABS LTD
17 1IVAX SUB TEVA PHARMS
18 3JANSSEN PHARMS
19 1KOWA PHARMS
20 3LUPIN LTD
21 2MACLEODS PHARMS LTD
22 1MERRO PHARM USA
23 1MICRO LABS LTD INDIA
24 4MYLAN
25 1MYLAN PHARMS INC
26 1NORTHSTAR HLTHCARE
27 1NOSTRUM LABS INC
28 1PLIVA
29 3PURDUE PHARMA
30 1RISING
31 4RUBICON
32 1SHIONOGI INC
33 1SPECGX LLC
34 6SUN PHARM
35 2SUN PHARM INDS INC
36 1SUN PHARM INDUSTRIES
37 1TEVA
38 1UNICHEM
39 3VALEANT PHARMS
40 1WATSON LABS
41 2ZYDUS PHARMS USA INC
01 4CAPSULE, EXTENDED RELEASE;ORAL
02 1SOLUTION;ORAL
03 30TABLET, EXTENDED RELEASE;ORAL
04 1TABLET, ORALLY DISINTEGRATING;ORAL
05 44TABLET;ORAL
01 47DISCN
02 33RX
01 4CONZIP
02 1QDOLO
03 1RYBIX ODT
04 3RYZOLT
05 1SEGLENTIS
06 53TRAMADOL HYDROCHLORIDE
07 11TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
08 1ULTRACET
09 2ULTRAM
10 3ULTRAM ER
01 65No
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 : RX
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
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Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
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 :
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 :
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 :
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 :
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