01 1ACTAVIS LABS FL INC
02 1AMNEAL PHARMS
03 1APPCO
04 1INGENUS PHARMS LLC
05 2KING PHARMS
06 1LANNETT CO INC
07 1MOUNTAIN
08 1PRIMUS PHARMS
09 1SANDOZ
10 2SCIEGEN PHARMS INC
01 12TABLET;ORAL
01 4DISCN
02 8RX
01 10METAXALONE
02 2SKELAXIN
01 9No
02 3Yes
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Approval Date : 2017-06-15
Application Number : 203695
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Approval Date : 2013-06-21
Application Number : 203399
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Approval Date : 2016-11-22
Application Number : 204770
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : SKELAXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 13217
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : SKELAXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2002-08-30
Application Number : 13217
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2015-06-01
Application Number : 22503
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Approval Date : 2010-03-31
Application Number : 40445
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 800MG
Approval Date : 2017-08-31
Application Number : 207466
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Approval Date : 2020-03-13
Application Number : 207466
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Brand Name : METAXALONE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Approval Date : 2015-02-27
Application Number : 40486
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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