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01 2ANDA Repository
02 1ANGITA PHARMA INC.
03 5Actavis Inc
04 2Adcock Ingram
05 2AiPing Pharmaceutical Inc
06 3Apotex Inc
07 2Aspire Lifesciences Pvt Ltd
08 1Auro Pharma Inc
09 4Aurobindo Pharma Limited
10 3Chartwell Pharmaceuticals llc
11 2Eurofarma Laboratorios S.A
12 1Grupo Azevedos
13 2InvaGen Pharmaceuticals Inc
14 3Inventia Healthcare Limited
15 1JAMP PHARMA
16 2Johnson & Johnson Innovative Medicine
17 3Jubilant Cadista Pharmaceuticals
18 2KVK.Tech
19 1LABORATOIRE RIVA INC.
20 2Macleods Pharmaceuticals Limited
21 2Novast Laboratories
22 2Oxford Pharm
23 1PRO DOC LIMITEE
24 2Par Pharmaceutical
25 2Pharmascience Inc.
26 1Pliva Hrvatska
27 2Prinston
28 1Ravoos Laboratories
29 6Rising Pharmaceuticals Inc
30 3Rubicon Research
31 1SANIS HEALTH INC
32 1SIT LABORATORIO FARMAC. Srl
33 1SIVEM PHARMACEUTICALS ULC
34 1Sandoz B2B
35 2Sudarshan Pharma
36 3Sun Pharmaceutical Industries Limited
37 2TWi Pharmaceuticals
38 3Teva Pharmaceutical Industries
39 1Tonix Pharmaceuticals Holding Corp
40 3Unichem Pharmaceuticals USA, Inc
41 1Viatris
42 6Blank
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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 1Hard Capsule
09 2Pellets
10 1SR Pellets
11 11TABLET
12 44TABLET;ORAL
13 1TABLET;SUBLINGUAL
14 2Tablet
15 1Tablets
16 3Blank
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01 1Authorized
02 2Countries Registered In: US (Filed 2018)
03 13DISCN
04 2Originator
05 11Prescription
06 42RX
07 20Blank
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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 2FLEXERIL
10 1Flexiban
11 1JAMP-CYCLOBENZAPRINE
12 1Myprocam 15
13 1Myprocam 30
14 2PMS-CYCLOBENZAPRINE - TAB 10MG
15 1PRO-CYCLOBENZAPRINE
16 1RIVA-CYCLOBENZAPRINE
17 1TEVA-CYCLOBENZAPRINE
18 1TONMYA
19 1Yurelax
20 17Blank
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01 4Brazil
02 11Canada
03 13India
04 1Italy
05 1Portugal
06 2South Africa
07 1Spain
08 57USA
09 1Blank
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 : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2006-02-03
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