01 2ANDA Repository
02 1ANGITA PHARMA INC.
03 5Actavis Inc
04 2AiPing Pharmaceutical Inc
05 3Apotex Inc
06 2Aspire Lifesciences Pvt Ltd
07 1Auro Pharma Inc
08 4Aurobindo Pharma Limited
09 3Chartwell Pharmaceuticals llc
10 2Eurofarma Laboratorios S.A
11 3Graviti Pharmaceuticals
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 3Rising Pharmaceuticals Inc
29 3Rubicon Research
30 1SANIS HEALTH INC
31 1SIT LABORATORIO FARMAC. Srl
32 1SIVEM PHARMACEUTICALS ULC
33 1Sandoz B2B
34 2Sudarshan Pharma
35 3Sun Pharmaceutical Industries Limited
36 2TWi Pharmaceuticals
37 3Teva Pharmaceutical Industries
38 3Unichem Pharmaceuticals USA, Inc
39 6Blank
01 2CAPSULE, EXTENDED RELEASE; ORAL
02 10CAPSULE, EXTENDED RELEASE;ORAL
03 4Coated Tablet
04 4ER Pellets
05 2Extended Release Capsule
06 1Extended Release Pellet
07 2Pellets
08 11TABLET
09 44TABLET;ORAL
10 2Tablet
11 1Tablets
12 3Blank
01 2Countries Registered In: US (Filed 2018)
02 13DISCN
03 1Prescription
04 41RX
05 29Blank
01 1AG-CYCLOBENZAPRINE
02 2AMRIX
03 1APO-CYCLOBENZAPRINE
04 1AURO-CYCLOBENZAPRINE
05 1BENZOMAC 15
06 1BENZOMAC 30
07 2CYCLOBENZAPRINE
08 1CYCLOBENZAPRINE - 10
09 52CYCLOBENZAPRINE HYDROCHLORIDE
10 2FLEXERIL
11 1Flexiban
12 1JAMP-CYCLOBENZAPRINE
13 2PMS-CYCLOBENZAPRINE - TAB 10MG
14 1RIVA-CYCLOBENZAPRINE
15 1TEVA-CYCLOBENZAPRINE
16 16Blank
01 4Brazil
02 11Canada
03 12India
04 1Italy
05 1Portugal
06 56USA
07 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 : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-04-18
Application Number : 78218
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 : 2015-06-19
Application Number : 78218
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 : 2020-11-03
Application Number : 78218
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 : 5MG
Packaging :
Approval Date : 2006-04-19
Application Number : 77563
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2006-04-19
Application Number : 77563
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 : 2017-08-25
Application Number : 77563
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 : 2011-02-28
Application Number : 78048
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2011-02-28
Application Number : 78048
Regulatory Info : RX
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 : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2007-02-28
Application Number : 77797
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2007-02-28
Application Number : 77797
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 : 1991-05-30
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
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