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Approved Drug Products containing Tramadol listed in the FDA Orange Book. Original Data : FDA Website

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01 1ATHENA

02 3STRIDES PHARMA

03 1ACCORD HLTHCARE

04 1ACI

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 3ENDO OPERATIONS

16 3GRAVITI PHARMS

17 1IPCA LABS LTD

18 1IVAX SUB TEVA PHARMS

19 3JANSSEN PHARMS

20 1KOWA PHARMS

21 3LUPIN LTD

22 2MACLEODS PHARMS LTD

23 1MERRO PHARM USA

24 1MICRO LABS LTD INDIA

25 4MYLAN

26 1MYLAN PHARMS INC

27 1NORTHSTAR HLTHCARE

28 1NOSTRUM LABS INC

29 1PLIVA

30 3PURDUE PHARMA

31 1RISING

32 4RUBICON

33 1SHIONOGI INC

34 1SPECGX LLC

35 6SUN PHARM

36 2SUN PHARM INDS INC

37 1SUN PHARM INDUSTRIES

38 1TEVA

39 1UNICHEM

40 3VALEANT PHARMS

41 1WATSON LABS

42 2ZYDUS PHARMS USA INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAthena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

RLD : Yes

TE Code :

TRAMADOL HYDROCHLORIDE

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 :

Athena Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

TRAMADOL HYDROCHLORIDE

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 :

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

TRAMADOL HYDROCHLORIDE

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 :

Strides Pharma Science

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

TRAMADOL HYDROCHLORIDE

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 :

Strides Pharma Science

05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TRAMADOL HYDROCHLORIDE

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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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TRAMADOL HYDROCHLORIDE

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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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TRAMADOL HYDROCHLORIDE

Brand Name : ULTRAM ER

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 300MG **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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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TRAMADOL HYDROCHLORIDE

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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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

TRAMADOL HYDROCHLORIDE

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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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

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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