01 1ACCORD HLTHCARE
02 6ALPHARMA PHARMS
03 1BARR
04 1CHARTWELL
05 1ELITE LABS
06 1FOSUN PHARMA
07 1NALPROPION
08 6PFIZER
09 3SPECGX LLC
10 1SUN PHARM
11 1TEVA WOMENS
01 12CAPSULE, EXTENDED RELEASE;ORAL
02 1TABLET, EXTENDED RELEASE;ORAL
03 10TABLET;ORAL
01 14DISCN
02 9RX
01 1CONTRAVE
02 6EMBEDA
03 9NALTREXONE HYDROCHLORIDE
04 1REVIA
05 6TROXYCA ER
01 15No
02 8Yes
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Brand Name : EMBEDA
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2009-08-13
Application Number : 22321
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : NALTREXONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 1998-05-08
Application Number : 74918
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : NALTREXONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 1999-05-26
Application Number : 75274
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : NALTREXONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 2000-03-08
Application Number : 75434
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : REVIA
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date : 1984-11-20
Application Number : 18932
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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