Diethylpropion Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2014-07-08)
Oldest Current Product
1959-08-06
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DIETHYLPROPION
FDAOB
ORAL\TABLET\DIETHYLPROPION HYDROCHLORIDE
SPL Active
ORAL\TABLET\DIETHYLPROPION HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\DIETHYLPROPION

product(s) by strength(s)

diethylpropion hydrochloride 25 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910783NDAWatson Laboratories, Inc.1959-08-06DIETHYLPROPION HYDROCHLORIDEORALTABLETNDA011722a750a1ef-8f3e-4870-97eb-3697aaca1818

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271475ANDALannett Company, Inc.2011-07-18DIETHYLPROPION HYDROCHLORIDEORALTABLETANDA2001774fdbc049-6497-4ea0-8788-d2b2963328f7
2107020044ANDAKvk-Tech, Inc.2010-12-27DIETHYLPROPION HYDROCHLORIDEORALTABLETANDA2012123ecb7bd7-e04c-47fe-859a-8ba8a54f9aff
3647200208ANDACorepharma, Llc2008-11-06DIETHYLPROPION HYDROCHLORIDEORALTABLETANDA040828701ba14c-e668-4308-8430-765a7aad47fa

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340530NDAApotheca, Inc1999-08-16DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA0117220971fa2e-d660-48b0-9fbb-96a2db167b92
2332610353ANDAAidarex Pharmaceuticals Llc2010-12-27DIETHYLPROPION HYDROCHLORIDEORALTABLET107020044ANDA201212f9db1711-d3b3-42dc-a5c5-621ab774df20
3430630348ANDAPd-Rx Pharmaceuticals, Inc.2010-12-27DIETHYLPROPION HYDROCHLORIDEORALTABLET107020044ANDA201212ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10
4500900326NDAA-S Medication Solutions Llc1959-08-06DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA0117226c57f874-73b4-4769-8947-0b0b3c5dac1d
5500900327ANDAA-S Medication Solutions Llc2010-12-27DIETHYLPROPION HYDROCHLORIDEORALTABLET107020044ANDA201212fca52c33-b2c9-46cb-affc-2d6d23730f37
6504364164ANDAUnit Dose Services2010-12-27DIETHYLPROPION HYDROCHLORIDEORALTABLET107020044ANDA20121231b58e5e-60af-4466-bd20-4b648e867e64
7545692059NDAA-S Medication Solutions Llc1959-08-06DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA011722fb11ae5d-d9b0-409f-be67-ba1c3b327549
8548681462NDAPhysicians Total Care, Inc.2004-06-14DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA011722330965ca-154f-42d2-bb7c-9494bf036c92
9552890794NDAPd-Rx Pharmaceuticals, Inc.2008-01-01DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA011722355a06ff-557d-4252-884d-8f3ee165b658
10636294010NDABryant Ranch Prepack2008-01-01DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA011722d6ef01d5-791a-ac09-39c0-de1f6e035c65
11683870695NDAKeltman Pharmaceuticals Inc.2010-06-07DIETHYLPROPION HYDROCHLORIDEORALTABLET005910783NDA01172204bd05c4-0d36-4580-94ec-2119d8d58644

application(s)

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

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
8ANDA200177_001RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseAA2011-07-18DIETHYLPROPION HYDROCHLORIDE
9ANDA201212_001RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseAA2010-12-22DIETHYLPROPION HYDROCHLORIDE
10NDA011673_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseTEPANIL
11NDA011722_002RXDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETTrueAATENUATE
12NDA017668_001discontinuedDIETHYLPROPION HYDROCHLORIDE (25MG)ORALTABLETFalseTENUATE

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.repack2010-06-141683870695, 683870696Diethylpropion Extended Release Oral Tablet
20971fa2e-d660-48b0-9fbb-96a2db167b92 (view SPL)DIETHYLPROPION HYDROCHLORIDE 25MG TABLETS USP DIETHYLPROPION HYDROCHLORIDE 75MG ER TABLETS USP Rx ONLY CIVprescriptionHuman PrescriptionApotheca, Increlabel, repack2010-04-301126340530, 126340691Diethylpropion Extended Release Oral Tablet
331b58e5e-60af-4466-bd20-4b648e867e64 (view SPL)Diethylpropion HCl USP CIV 25 mg TabletsprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-01-263504364164
4330965ca-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, repack2012-03-277548681462, 548681463Diethylpropion Extended Release Oral Tablet
5355a06ff-557d-4252-884d-8f3ee165b658 (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.repack2009-11-253552890794
63ecb7bd7-e04c-47fe-859a-8ba8a54f9aff (view SPL)Diethylpropion HCl USP CIV 25 mg TabletsprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2011-01-264107020044
74fdbc049-6497-4ea0-8788-d2b2963328f7 (view SPL)Diethylpropion Hydrochloride Tablets USP, 25 mgprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-07-203005271475
86c57f874-73b4-4769-8947-0b0b3c5dac1d (view SPL)70025263Diethylpropion HCl USP C-IVImmediate-Release25 mg TabletsDiethylpropion HCl USP C-IVControlled-Release75 mg TabletsRx onlyRev.March 2014prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-141500900326, 500900121Diethylpropion Extended Release Oral Tablet
9701ba14c-e668-4308-8430-765a7aad47fa (view SPL)Diethylpropion Hydrochloride Tablets USP 25 mg Rx onlyprescriptionHuman PrescriptionCorepharma, LlcANALYSIS, LABEL, MANUFACTURE, PACK2011-12-196647200208
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.2014-07-084005910783, 005910782Diethylpropion Extended Release Oral Tablet
11ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10 (view SPL)Diethylpropion HCl USP CIV 25 mg TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-266430630348
12d6ef01d5-791a-ac09-39c0-de1f6e035c65 (view SPL)DIETHYLPROPION HCL IMMEDIATE-RELEASEprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-173636294010
13f9db1711-d3b3-42dc-a5c5-621ab774df20 (view SPL)Diethylpropion HCl USP CIV 25 mg TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-271332610353
14fb11ae5d-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 Llcrepack2013-04-271545692059, 545690396Diethylpropion Extended Release Oral Tablet
15fca52c33-b2c9-46cb-affc-2d6d23730f37 (view SPL)Diethylpropion HCl USP CIV 25 mg TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900327

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