Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
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01 2CAP
02 2CAPSULE, EXTENDED RELEASE; ORAL
03 10CAPSULE, EXTENDED RELEASE;ORAL
04 4Coated Tablet
05 4ER Pellets
06 2Extended Release Capsule
07 1Extended Release Pellet
08 3Pellets
09 1SR Pellets
10 11TABLET
11 44TABLET;ORAL
12 2Tablet
13 1Tablets
14 3Blank
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01 2Countries Registered In: US (Filed 2018)
02 13DISCN
03 2Originator
04 1Prescription
05 41RX
06 31Blank
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01 1AG-CYCLOBENZAPRINE
02 2AMRIX
03 1APO-CYCLOBENZAPRINE
04 1AURO-CYCLOBENZAPRINE
05 1BENZOMAC 15
06 1BENZOMAC 30
07 2CYCLOBENZAPRINE
08 52CYCLOBENZAPRINE HYDROCHLORIDE
09 1Cyclobenzaprine
10 2FLEXERIL
11 1Flexiban
12 1JAMP-CYCLOBENZAPRINE
13 1Myprocam 15
14 1Myprocam 30
15 2PMS-CYCLOBENZAPRINE - TAB 10MG
16 1PRO-CYCLOBENZAPRINE
17 1RIVA-CYCLOBENZAPRINE
18 1TEVA-CYCLOBENZAPRINE
19 17Blank
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01 4Brazil
02 11Canada
03 14India
04 1Italy
05 1Portugal
06 2South Africa
07 56USA
08 1Blank
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Regulatory Info :
Registration Country : India
Brand Name : Cyclobenzaprine
Dosage Form : Pellets
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1989-05-03
Application Number : 71611
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2006-02-03
Application Number : 71611
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG
Packaging :
Approval Date : 2006-02-03
Application Number : 71611
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1991-11-27
Application Number : 73143
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1994-11-30
Application Number : 74436
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1991-11-19
Application Number : 72854
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2006-02-03
Application Number : 72854
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1995-05-23
Application Number : 73541
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2006-04-06
Application Number : 73541
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLEXERIL
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 17821
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLEXERIL
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 17821
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2005-10-04
Application Number : 77209
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1995-09-29
Application Number : 74421
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1991-05-30
Application Number : 73144
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2006-02-03
Application Number : 73144
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG
Packaging :
Approval Date : 2013-03-25
Application Number : 73144
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1993-02-26
Application Number : 73683
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : AMRIX
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2007-02-01
Application Number : 21777
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : AMRIX
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2007-02-01
Application Number : 21777
Regulatory Info : RX
Registration Country : USA