Benzphetamine Oral Tablet

Brand(s)
Didrex, Regimex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Kvk-Tech, Inc. (2010-07-21)
Oldest Current Product
1960-10-26
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BENZPHETAMINE
FDAOB
ORAL\TABLET\BENZPHETAMINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\BENZPHETAMINE HYDROCHLORIDE
ORAL\TABLET\BENZPHETAMINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\BENZPHETAMINE
ORAL\TABLET\BENZPHETAMINE

product(s) by strength(s)

benzphetamine hydrochloride 25 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1669920399RegimexANDAWraser Pharmaceuticals2013-02-01BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA0904731a5d7233-4453-42a5-8144-a4276db39660

benzphetamine hydrochloride 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151205ANDAGlobal Pharmaceuticals2008-12-01BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA040845fdabc130-335d-4fb3-bda8-d669a1e02a18
2004636050ANDAC.O. Truxton, Inc.2011-11-01BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA0904730bb7f0d2-2fb8-4e6f-a96e-cc0e99b3e150
3107020040ANDAKvk-Tech, Inc.2010-07-21BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA09096814d4589d-7f1c-4b6e-9557-59dad39b0960
4231550174ANDAHeritage Pharmaceuticals Inc.2012-10-19BENZPHETAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA2020613fd6b3a8-b17b-4b98-ad03-a8af7b6f3368
5435470263ANDASolco Healthcare U.S., Llc2011-08-01BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA090473d0c7f688-ff7f-4085-b098-210c4e47c5a1
6466720844ANDAMikart, Inc.2011-11-01BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA09047376c76f8e-d8e8-429a-ba67-c270e5ac6c83
7643760650ANDABoca Pharmacal, Llc2010-09-07BENZPHETAMINE HYDROCHLORIDEORALTABLETANDA0407471d1c0666-dfe4-4c98-b345-801eb78b5da8

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1000090024DidrexNDAPharmacia And Upjohn Company1960-10-26BENZPHETAMINE HYDROCHLORIDEORALTABLETNDA012427fe6d8813-25d9-4e56-84c7-ca6c3111a19a
2500900118DidrexNDAA-S Medication Solutions Llc1960-10-26BENZPHETAMINE HYDROCHLORIDEORALTABLET000090024NDA012427165a1ba0-43e1-4227-be36-629a8b0a25e5
3545690389DidrexNDAA-S Medication Solutions Llc1960-10-26BENZPHETAMINE HYDROCHLORIDEORALTABLET000090024NDA012427dc2f9a0c-b7d9-433e-b736-ce4f36658c03
4552890432DidrexNDAPd-Rx Pharmaceuticals, Inc.1960-10-26BENZPHETAMINE HYDROCHLORIDEORALTABLET000090024NDA012427b2f498c3-9503-431e-b3be-d4f01356e979

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340118ANDAApotheca, Inc2009-12-09BENZPHETAMINE HYDROCHLORIDEORALTABLET643760650ANDA040747e95dfb31-8365-498d-91ea-79738033f905
2332610458ANDAAidarex Pharmaceuticals Llc2010-07-21BENZPHETAMINE HYDROCHLORIDEORALTABLET107020040ANDA090968082a9bcf-f1ea-4c77-86e0-3699720514be
3430630425ANDAPd-Rx Pharmaceuticals, Inc.2011-11-01BENZPHETAMINE HYDROCHLORIDEORALTABLET004636050ANDA090473cb48a1ec-c977-4766-b615-f7ddbb2c2f79
4430630541ANDAPd-Rx Pharmaceuticals, Inc.2010-07-21BENZPHETAMINE HYDROCHLORIDEORALTABLET107020040ANDA0909682b7014af-0cc9-4199-90f2-ec07ac02f8cf
5500901024ANDAA-S Medication Solutions Llc2010-07-21BENZPHETAMINE HYDROCHLORIDEORALTABLET107020040ANDA090968a15e3b4b-9874-4848-9599-38e110a37b6b
6545695912ANDAA-S Medication Solutions Llc2010-07-21BENZPHETAMINE HYDROCHLORIDEORALTABLET107020040ANDA090968b9ce27f6-446c-4418-97d5-60822538adaa
7552890158ANDAPd-Rx Pharmaceuticals, Inc.2009-12-09BENZPHETAMINE HYDROCHLORIDEORALTABLET643760650ANDA0407471041306e-357a-45ee-ab3c-3cca28edad4e
8636294139ANDABryant Ranch Prepack2010-02-01BENZPHETAMINE HYDROCHLORIDEORALTABLET643760650ANDA0408454f4a726a-8ac1-4a37-89ec-da1406784195

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040578BENZPHETAMINE HYDROCHLORIDEPADDOCK LABORATORIES INC2006-04-17ANDA040578_001
2ANDA040714BENZPHETAMINE HYDROCHLORIDETrueCOREPHARMA LLC2007-10-29ANDA040714_001
3ANDA040747BENZPHETAMINE HYDROCHLORIDETEDOR PHARMA INC2007-03-30ANDA040747_001
4ANDA040773BENZPHETAMINE HYDROCHLORIDEMALLINCKRODT INC2007-04-25ANDA040773_001
5ANDA040845BENZPHETAMINE HYDROCHLORIDEIMPAX LABORATORIES INC2008-11-18ANDA040845_001
6ANDA090473BENZPHETAMINE HYDROCHLORIDEMIKART INC2010-09-15ANDA090473_001, ANDA090473_002
7ANDA090968BENZPHETAMINE HYDROCHLORIDEKVK TECH INC2010-07-20ANDA090968_001
8ANDA202061BENZPHETAMINE HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2012-01-27ANDA202061_001
9NDA012427DIDREXTruePHARMACIA AND UPJOHN CONDA012427_002, NDA012427_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040578_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2006-04-17BENZPHETAMINE HYDROCHLORIDE
2ANDA040714_001discontinuedBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalse2007-10-29BENZPHETAMINE HYDROCHLORIDE
3ANDA040747_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2007-03-30BENZPHETAMINE HYDROCHLORIDE
4ANDA040773_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2007-04-25BENZPHETAMINE HYDROCHLORIDE
5ANDA040845_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2008-11-18BENZPHETAMINE HYDROCHLORIDE
6ANDA090473_001RXBENZPHETAMINE HYDROCHLORIDE (25MG)ORALTABLETFalseAA2010-09-15BENZPHETAMINE HYDROCHLORIDE
7ANDA090473_002RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2010-09-15BENZPHETAMINE HYDROCHLORIDE
8ANDA090968_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETTrueAA2010-07-20BENZPHETAMINE HYDROCHLORIDE
9ANDA202061_001RXBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAA2012-01-27BENZPHETAMINE HYDROCHLORIDE
10NDA012427_002discontinuedBENZPHETAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseDIDREX
11NDA012427_003discontinuedBENZPHETAMINE HYDROCHLORIDE (25MG)ORALTABLETFalseDIDREX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1082a9bcf-f1ea-4c77-86e0-3699720514be (view SPL)Benzphetamine Hydrochloride TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-231332610458
20bb7f0d2-2fb8-4e6f-a96e-cc0e99b3e150 (view SPL)prescriptionHuman PrescriptionC.O. Truxton, Inc.2011-11-011004636050
31041306e-357a-45ee-ab3c-3cca28edad4e (view SPL)BENZPHETAMINE HYDROCHLORIDE 50MG USP CIII RX ONLYprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-03-116552890158
414d4589d-7f1c-4b6e-9557-59dad39b0960 (view SPL)Benzphetamine Hydrochloride TabletsprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2010-07-211107020040
5165a1ba0-43e1-4227-be36-629a8b0a25e5 (view SPL)Didrex CIII brand of benzphetamine hydrochloride tabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-141500900118
61a5d7233-4453-42a5-8144-a4276db39660 (view SPL)prescriptionHuman PrescriptionWraser Pharmaceuticals2013-03-131669920399
71d1c0666-dfe4-4c98-b345-801eb78b5da8 (view SPL)Rx OnlyprescriptionHuman PrescriptionBoca Pharmacal, LlcAPI MANUFACTURE, MANUFACTURE, REPACK2013-09-1013643760650
82b7014af-0cc9-4199-90f2-ec07ac02f8cf (view SPL)Benzphetamine Hydrochloride TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-10-226430630541
93fd6b3a8-b17b-4b98-ad03-a8af7b6f3368 (view SPL)prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2013-10-2210231550174
104f4a726a-8ac1-4a37-89ec-da1406784195 (view SPL)Benzphetamine Hydrochloride 50mgprescriptionHuman PrescriptionBryant Ranch Prepackrepack2012-10-122636294139
1176c76f8e-d8e8-429a-ba67-c270e5ac6c83 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2011-11-011466720844
12a15e3b4b-9874-4848-9599-38e110a37b6b (view SPL)Benzphetamine Hydrochloride TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500901024
13b2f498c3-9503-431e-b3be-d4f01356e979 (view SPL)Didrex CIII brand of benzphetamine hydrochloride tabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-02-017552890432
14b9ce27f6-446c-4418-97d5-60822538adaa (view SPL)Benzphetamine Hydrochloride TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-03-041545695912
15cb48a1ec-c977-4766-b615-f7ddbb2c2f79 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-11-011430630425
16d0c7f688-ff7f-4085-b098-210c4e47c5a1 (view SPL)BENZPHETAMINE HYDROCHLORIDE TABLETS, 50 MGprescriptionHuman PrescriptionSolco Healthcare U.S., LlcMANUFACTURE2011-07-071435470263
17dc2f9a0c-b7d9-433e-b736-ce4f36658c03 (view SPL)Didrex CIII brand of benzphetamine hydrochloride tabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-04-191545690389
18e95dfb31-8365-498d-91ea-79738033f905 (view SPL)BENZPHETAMINE HYDROCHLORIDE 50MG USP CIII RX ONLYprescriptionHuman PrescriptionApotheca, Inc2010-03-113126340118
19fdabc130-335d-4fb3-bda8-d669a1e02a18 (view SPL)Benzphetamine Hydrochloride Tablets, 50 mgCIIIprescriptionHuman PrescriptionGlobal PharmaceuticalsREPACK2010-05-263001151205
20fe6d8813-25d9-4e56-84c7-ca6c3111a19a (view SPL)Didrex CIII brand of benzphetamine hydrochloride tabletsprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, MANUFACTURE2011-02-017000090024

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII