Diethylpropion Extended Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2014-07-08)
Oldest Current Product
1960-11-17
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DIETHYLPROPION
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DIETHYLPROPION HYDROCHLORIDE
ORAL\TABLET\DIETHYLPROPION HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\DIETHYLPROPION HYDROCHLORIDE
ORAL\TABLET\DIETHYLPROPION HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\DIETHYLPROPION
ORAL\TABLET\DIETHYLPROPION

product(s) by strength(s)

24 hr diethylpropion hydrochloride 75 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910782NDAWatson Laboratories, Inc.1960-11-17DIETHYLPROPION HYDROCHLORIDEORALTABLETNDA012546a750a1ef-8f3e-4870-97eb-3697aaca1818

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271477ANDALannett Company, Inc.2011-10-24DIETHYLPROPION HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA091680dab53f4f-68d4-4477-a2b6-ad44a956332b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440598NDABlenheim Pharmacal, Inc.2010-03-30DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA011722ba26f274-f385-49be-aef1-7041d146b9f7
2126340691NDAApotheca, Inc2008-10-23DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA0117220971fa2e-d660-48b0-9fbb-96a2db167b92
3216950876NDARebel Distributors Corp2008-01-01DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA011722b26c2f51-7436-4622-a174-3f3978a1fda2
4332610354ANDAAidarex Pharmaceuticals Llc2011-10-24DIETHYLPROPION HYDROCHLORIDEORALTABLET, EXTENDED RELEASE005271477ANDA09168019cfb2fd-f657-4f97-9494-43b909967cfa
5430630532ANDAPd-Rx Pharmaceuticals, Inc.2011-10-24DIETHYLPROPION HYDROCHLORIDEORALTABLET, EXTENDED RELEASE005271477ANDA0916800d213a24-ebbf-41df-8f32-de44a572829e
6500900120ANDAA-S Medication Solutions Llc2011-10-24DIETHYLPROPION HYDROCHLORIDEORALTABLET, EXTENDED RELEASE005271477ANDA09168004f1a804-00f1-48f5-acfa-0ed1a8544784
7500900121NDAA-S Medication Solutions Llc1960-11-17DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA0125466c57f874-73b4-4769-8947-0b0b3c5dac1d
8545690396NDAA-S Medication Solutions Llc1960-11-17DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA012546fb11ae5d-d9b0-409f-be67-ba1c3b327549
9548681463NDAPhysicians Total Care, Inc.2005-10-03DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA012546330965ca-154f-42d2-bb7c-9494bf036c92
10552890368NDAPd-Rx Pharmaceuticals, Inc.2008-01-01DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA0117223a283f1b-486f-4100-8f97-aa0350cc9b8d
11636292967NDABryant Ranch Prepack2008-01-01DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA011722af3d7879-7160-5b02-01e4-bd02f53c8018
12683870696NDAKeltman Pharmaceuticals Inc.2010-06-07DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA01172204bd05c4-0d36-4580-94ec-2119d8d58644
13687880686NDAPreferred Pharmaceuticals, Inc.2014-02-12DIETHYLPROPION HYDROCHLORIDEORALTABLET005910782NDA012546f04ddced-764f-4197-816e-a171164df2ac
14687889423ANDAPreferred Pharmaceuticals, Inc.2014-04-29DIETHYLPROPION HYDROCHLORIDEORALTABLET, EXTENDED RELEASE005271477ANDA0916804bf6ac3d-78e9-4110-809b-791a36c11622

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040828DIETHYLPROPION HYDROCHLORIDECOREPHARMA LLC2008-11-05ANDA040828_001Diethylpropion Oral Tablet
2ANDA085544DIETHYLPROPION HYDROCHLORIDETrueUCB INCANDA085544_001Diethylpropion Oral Tablet
3ANDA085741DIETHYLPROPION HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085741_001Diethylpropion Oral Tablet
4ANDA085916DIETHYLPROPION HYDROCHLORIDETrueSANDOZ INCANDA085916_001Diethylpropion Oral Tablet
5ANDA088267DIETHYLPROPION HYDROCHLORIDETrueTG UNITED LABS LLC1983-08-25ANDA088267_001Diethylpropion Oral Tablet
6ANDA088268DIETHYLPROPION HYDROCHLORIDETrueTG UNITED LABS LLC1983-08-25ANDA088268_001Diethylpropion Oral Tablet
7ANDA088642DIETHYLPROPION HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1984-09-20ANDA088642_001Diethylpropion Oral Tablet
8ANDA091680DIETHYLPROPION HYDROCHLORIDELANNETT HOLDINGS INC2011-10-24ANDA091680_001
9ANDA200177DIETHYLPROPION HYDROCHLORIDELANNETT HOLDINGS INC2011-07-18ANDA200177_001Diethylpropion Oral Tablet
10ANDA201212DIETHYLPROPION HYDROCHLORIDEAVANTHI INC2010-12-22ANDA201212_001Diethylpropion Oral Tablet
11NDA011673TEPANILTrue3M PHARMACEUTICALS INCNDA011673_001Diethylpropion Oral Tablet
12NDA011722TENUATEACTAVIS LABORATORIES UT INCNDA011722_002Diethylpropion Oral Tablet
13NDA012546TENUATE DOSPANACTAVIS LABORATORIES UT INCNDA012546_001
14NDA017668TENUATETrueSANOFI AVENTIS US LLCNDA017668_001Diethylpropion Oral Tablet
15NDA017669TENUATETrueSANOFI AVENTIS US LLCNDA017669_001
16NDA017956TEPANIL TEN-TABTrue3M PHARMACEUTICALS INCNDA017956_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040828_001RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseAA2008-11-05DIETHYLPROPION HYDROCHLORIDE
2ANDA085544_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseDIETHYLPROPION HYDROCHLORIDE
3ANDA085741_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseDIETHYLPROPION HYDROCHLORIDE
4ANDA085916_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseDIETHYLPROPION HYDROCHLORIDE
5ANDA088267_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalse1983-08-25DIETHYLPROPION HYDROCHLORIDE
6ANDA088268_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalse1983-08-25DIETHYLPROPION HYDROCHLORIDE
7ANDA088642_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalse1984-09-20DIETHYLPROPION HYDROCHLORIDE
8ANDA091680_001RXDIETHYLPROPION HYDROCHLORIDE (75MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-10-24DIETHYLPROPION HYDROCHLORIDE
9ANDA200177_001RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseAA2011-07-18DIETHYLPROPION HYDROCHLORIDE
10ANDA201212_001RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseAA2010-12-22DIETHYLPROPION HYDROCHLORIDE
11NDA011673_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseTEPANIL
12NDA011722_002RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETTrueAATENUATE
13NDA012546_001RXDIETHYLPROPION HYDROCHLORIDE (75MG)ORALTABLET, EXTENDED RELEASETrueABTENUATE DOSPAN
14NDA017668_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseTENUATE
15NDA017669_001discontinuedDIETHYLPROPION HYDROCHLORIDE (75MG)ORALTABLET, EXTENDED RELEASEFalseTENUATE
16NDA017956_001discontinuedDIETHYLPROPION HYDROCHLORIDE (75MG)ORALTABLET, EXTENDED RELEASEFalseTEPANIL TEN-TAB

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
104bd05c4-0d36-4580-94ec-2119d8d58644 (view SPL)Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg TabletsprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-06-141683870696, 683870695Diethylpropion Oral Tablet
204f1a804-00f1-48f5-acfa-0ed1a8544784 (view SPL)Diethylpropion Hydrochloride Extended Release Tablets, 75 mgCIVRx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-141500900120
30971fa2e-d660-48b0-9fbb-96a2db167b92 (view SPL)DIETHYLPROPION HYDROCHLORIDE 25MG TABLETS USP DIETHYLPROPION HYDROCHLORIDE 75MG ER TABLETS USP Rx ONLY CIVprescriptionHuman PrescriptionApotheca, Increlabel, repack2010-04-301126340691, 126340530Diethylpropion Oral Tablet
40d213a24-ebbf-41df-8f32-de44a572829e (view SPL)Diethylpropion Hydrochloride Extended Release Tablets, 75 mgCIVRx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-2412430630532
519cfb2fd-f657-4f97-9494-43b909967cfa (view SPL)Diethylpropion Hydrochloride Extended Release Tablets, 75 mgCIVRx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-271332610354
6330965ca-154f-42d2-bb7c-9494bf036c92 (view SPL)70015427Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev. March 2007prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-03-277548681463, 548681462Diethylpropion Oral Tablet
73a283f1b-486f-4100-8f97-aa0350cc9b8d (view SPL)70015427 Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-11-253552890368
84bf6ac3d-78e9-4110-809b-791a36c11622 (view SPL)Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-05-081687889423
96c57f874-73b4-4769-8947-0b0b3c5dac1d (view SPL)70025263Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev.March 2014prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-141500900121, 500900326Diethylpropion Oral Tablet
10a750a1ef-8f3e-4870-97eb-3697aaca1818 (view SPL)70025263Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev.March 2014prescriptionHuman PrescriptionWatson Laboratories, Inc.2014-07-084005910782, 005910783Diethylpropion Oral Tablet
11af3d7879-7160-5b02-01e4-bd02f53c8018 (view SPL)Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets RX OnlyprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2008-01-012636292967
12b26c2f51-7436-4622-a174-3f3978a1fda2 (view SPL)70015427 Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-242216950876
13ba26f274-f385-49be-aef1-7041d146b9f7 (view SPL)70015427 Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-262105440598
14dab53f4f-68d4-4477-a2b6-ad44a956332b (view SPL)Diethylpropion Hydrochloride Extended Release Tablets, 75 mgCIVRx onlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-10-2410005271477
15f04ddced-764f-4197-816e-a171164df2ac (view SPL)70025263 Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only Rev.March 2014prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-062687880686
16fb11ae5d-d9b0-409f-be67-ba1c3b327549 (view SPL)70015427Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev. March 2007prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-04-271545690396, 545692059Diethylpropion Oral Tablet

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