Loratadine Disintegrating Oral Tablet

Brand(s)
Alavert, Claritin
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Pfizer Consumer Healthcare (2014-09-25)
Oldest Current Product
2002-11-27
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\LORATADINE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\LORATADINE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\LORATADINE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\LORATADINE

product(s) by strength(s)

loratadine 10 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005732620AlavertNDAPfizer Consumer Healthcare2002-12-19LORATADINEORALTABLET, ORALLY DISINTEGRATINGNDA021375f45af3e4-5dd5-ea0a-c47c-8d68a1249158
2115234329ClaritinNDAMsd Consumer Care, Inc.2002-11-27LORATADINEORALTABLET, ORALLY DISINTEGRATINGNDA020704b681ea25-d00b-4c8a-8054-cc6f983ce337

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003630527ANDAWalgreens2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715307e54d8e-e129-4883-b688-a3510597b503
2009045806ANDAMajor2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153111e6cdf-04fa-49fa-8d5f-e5fc5bd55a8e
3116730311ANDATarget Corp2009-06-16LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA075990cf728502-2f76-4e09-b597-979e1dbbf4a6
4116730513ANDATarget Corp2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153e2fe073f-14da-424f-a34c-486d666fd649
5116730527ANDATarget Corp2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153e2fe073f-14da-424f-a34c-486d666fd649
6151270979ANDASelect Brand2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153abeae0a6-7f41-45e3-b2ae-145a2e633bc7
7211300527ANDABetter Living Brands Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153244e041f-20e2-4e38-ac6b-bf96f8724d5e
8243850161ANDAGood Neighbor Pharmacy2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715308bef2a7-c15f-4930-97c1-9d988e7b5181
9243850518ANDAGood Neighbor Pharmacy2004-03-15LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0759902f0ef205-49bb-4a74-b000-2f9823ec6179
10243850540ANDAGood Neighbor Pharmacy2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715308bef2a7-c15f-4930-97c1-9d988e7b5181
11368000212ANDATop Care (Topco Associates Llc)2005-03-02LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07599098de15d4-77a5-4ab6-af79-9a93e0115afc
12368000311ANDATop Care (Topco Associates Llc)2004-02-03LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0759900e689e73-c677-4fac-bc85-b2865fef2664
13368000527ANDATop Care (Topco Associates Llc)2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f9
14368000528ANDATop Care (Topco Associates Llc)2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715352e8e5c4-a552-4adf-b71b-9259e7822fae
15368000824ANDATop Care (Topco Associates Llc)2004-03-09LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA075990582c6956-ca82-441c-a3c8-c4b40d7daeec
16370120527ANDAShopko Stores Operating Co, Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771538d7cedb3-6edc-4e9d-9f18-08158d176fdd
17372050381ANDACardinal Health2004-02-25LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0759902db99c48-8632-4348-b33d-eda5db4b6488
18372050387ANDACardinal Health2004-02-25LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA075990368e5022-22d5-42ce-ba7d-c64d2b0f17d0
19372050745ANDACardinal Health2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153a899a3fd-ba7d-4a59-a53d-85eb154d8335
20411630311ANDASupervalu, Inc2004-08-05LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA075990d23d17a0-bdfb-4e5e-b5f2-b4af16e27380
21411630528ANDASupervalu, Inc2013-12-03LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153bc253aa7-686c-40e6-affa-a585b465046a
22412500513ANDAMeijer Distribution, Inc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715324961bee-132c-4347-a3f4-0518396999ea
23412500527ANDAMeijer Distribution, Inc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715324961bee-132c-4347-a3f4-0518396999ea
24415200513ANDAFoodhold U.S.A., Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715304a54364-7f13-4b23-8445-9cbc57733e18
25415200525ANDAFoodhold U.S.A., Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153178d708e-6091-4357-9dec-acfeb0cadfb3
26415200527ANDAFoodhold U.S.A., Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153178d708e-6091-4357-9dec-acfeb0cadfb3
27461220140ANDAAmerisource Bergen2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771533cb958e5-759a-4934-ac14-f75e3804778c
28493480634ANDASunmark2004-02-02LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07599024081205-4ff0-40a8-b554-2f2f7c1a3000
29493480637ANDASunmark2004-02-02LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0759908cb634b5-52bf-444a-baf5-740467091008
30493480929ANDASunmark2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771532aa10bc8-4d85-49c8-ad9b-7a555b26fe0d
31493480930ANDASunmark2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771532aa10bc8-4d85-49c8-ad9b-7a555b26fe0d
32516600527ANDAOhm Laboratories Inc.2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153de3a7725-5d1b-4195-a9f8-43f92888997c
33553150529ANDAFreds Inc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771535f246f7a-a221-49d1-94cb-526e0685f48c
34597790527ANDACvs2007-09-27LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153df4fbe7f-ab04-450f-903d-348b00575036
35620110073ANDAMckesson (Health Mart)2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA077153005948c5-97fe-4f07-81bb-33a691261c51
36638680157ANDAQuality Choice (Chain Drug Marketing Association)2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771537cc8edff-b6fb-4a5f-8053-ebfdd0f8e770
37639410528ANDABest Choice (Valu Merchandisers Company)2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA0771531fcc897d-bc89-4270-bf03-dc6c2abe1d18
38680160527ANDAChain Drug Consortium, Llc2007-08-31LORATADINEORALTABLET, ORALLY DISINTEGRATINGANDA07715326a7a473-3b88-4aa6-be56-da315e7556b6

loratadine 5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1115237202ClaritinNDAMsd Consumer Care, Inc.2006-12-12LORATADINEORALTABLET, ORALLY DISINTEGRATINGNDA0219937dc04b48-f053-4e4b-a493-9e8286d2a791

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA075822LORATADINEPFIZER INC2003-02-10ANDA075822_001Loratadine Oral Tablet
2ANDA075990LORATADINEACTAVIS LABORATORIES FL INC2003-11-03ANDA075990_001Loratadine Oral Tablet
3ANDA076011LORATADINEIMPAX LABORATORIES INC2003-09-29ANDA076011_001Loratadine Oral Tablet
4ANDA077153LORATADINE REDIDOSESUN PHARMACEUTICAL INDUSTRIES LTD2007-04-11ANDA077153_001Loratadine Oral Tablet
5NDA020704CLARITIN HIVES RELIEF REDITABBAYER HEALTHCARE LLC2002-11-27NDA020704_002, NDA020704_003Loratadine Oral Tablet
6NDA021375ALAVERTPFIZER INC2002-12-19NDA021375_001Loratadine Oral Tablet
7NDA021993CLARITIN REDITABSBAYER HEALTHCARE LLC2006-12-12NDA021993_001Loratadine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA075822_001OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2003-02-10LORATADINE
2ANDA075990_001OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2003-11-03LORATADINE
3ANDA076011_001OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2003-09-29LORATADINE
4ANDA077153_001OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2007-04-11LORATADINE REDIDOSE
5NDA020704_002OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGTrue2002-11-27CLARITIN HIVES RELIEF REDITAB
6NDA020704_003OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGTrue2003-11-19CLARITIN HIVES RELIEF REDITAB
7NDA021375_001OTCLORATADINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2002-12-19ALAVERT
8NDA021993_001OTCLORATADINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGTrue2006-12-12CLARITIN REDITABS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1005948c5-97fe-4f07-81bb-33a691261c51 (view SPL)Drug FactsotcHuman OTCMckesson (Health Mart)manufacture2012-08-101620110073
204a54364-7f13-4b23-8445-9cbc57733e18 (view SPL)Drug FactsotcHuman OTCFoodhold U.S.A., Llcmanufacture2013-01-141415200513
307e54d8e-e129-4883-b688-a3510597b503 (view SPL)Drug FactsotcHuman OTCWalgreensMANUFACTURE2015-03-313003630527
408bef2a7-c15f-4930-97c1-9d988e7b5181 (view SPL)Drug FactsotcHuman OTCGood Neighbor Pharmacymanufacture2012-10-311243850161, 243850540
50e689e73-c677-4fac-bc85-b2865fef2664 (view SPL)Topco Allergy Relief Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2009-07-211368000311
6111e6cdf-04fa-49fa-8d5f-e5fc5bd55a8e (view SPL)Drug FactsotcHuman OTCMajormanufacture2012-08-011009045806
7178d708e-6091-4357-9dec-acfeb0cadfb3 (view SPL)Drug FactsotcHuman OTCFoodhold U.S.A., Llcmanufacture2013-01-141415200525, 415200527
81fcc897d-bc89-4270-bf03-dc6c2abe1d18 (view SPL)Drug FactsotcHuman OTCBest Choice (Valu Merchandisers Company)manufacture2013-02-261639410528
924081205-4ff0-40a8-b554-2f2f7c1a3000 (view SPL)McKesson Loratadine Drug FactsotcHuman OTCSunmark2009-07-211493480634
10244e041f-20e2-4e38-ac6b-bf96f8724d5e (view SPL)Drug FactsotcHuman OTCBetter Living Brands Llcmanufacture2012-09-251211300527
1124961bee-132c-4347-a3f4-0518396999ea (view SPL)Drug FactsotcHuman OTCMeijer Distribution, Incmanufacture2012-09-211412500513, 412500527
1226a7a473-3b88-4aa6-be56-da315e7556b6 (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, LlcMANUFACTURE2015-10-083680160527
132aa10bc8-4d85-49c8-ad9b-7a555b26fe0d (view SPL)Drug FactsotcHuman OTCSunmarkMANUFACTURE2012-08-142493480929, 493480930
142db99c48-8632-4348-b33d-eda5db4b6488 (view SPL)Cardinal Health Allergy Relief Drug FactsotcHuman OTCCardinal Health2009-07-171372050381
152f0ef205-49bb-4a74-b000-2f9823ec6179 (view SPL)Amerisource Bergen Allergy Relief Drug FactsotcHuman OTCGood Neighbor Pharmacy2009-07-211243850518
16368e5022-22d5-42ce-ba7d-c64d2b0f17d0 (view SPL)Cardinal Health Allergy Relief Drug FactsotcHuman OTCCardinal Health2009-07-211372050387
173cb958e5-759a-4934-ac14-f75e3804778c (view SPL)Drug FactsotcHuman OTCAmerisource Bergenmanufacture2012-11-061461220140
1852e8e5c4-a552-4adf-b71b-9259e7822fae (view SPL)Drug FactsotcHuman OTCTop Care (Topco Associates Llc)manufacture2012-04-041368000528
19582c6956-ca82-441c-a3c8-c4b40d7daeec (view SPL)Topco Allergy Relief Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2009-07-171368000824
205f246f7a-a221-49d1-94cb-526e0685f48c (view SPL)Drug FactsotcHuman OTCFreds Incmanufacture2013-01-081553150529
21777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f9 (view SPL)Drug FactsotcHuman OTCTop Care (Topco Associates Llc)manufacture2012-08-282368000527
227cc8edff-b6fb-4a5f-8053-ebfdd0f8e770 (view SPL)Drug FactsotcHuman OTCQuality Choice (Chain Drug Marketing Association)manufacture2012-09-141638680157
237dc04b48-f053-4e4b-a493-9e8286d2a791 (view SPL)Claritin RediTabsotcHuman OTCMsd Consumer Care, Inc.2014-03-194115237202
248cb634b5-52bf-444a-baf5-740467091008 (view SPL)McKesson Allergy Relief Drug FactsotcHuman OTCSunmark2009-07-171493480637
258d7cedb3-6edc-4e9d-9f18-08158d176fdd (view SPL)Drug FactsotcHuman OTCShopko Stores Operating Co, Llcmanufacture2013-03-211370120527
2698de15d4-77a5-4ab6-af79-9a93e0115afc (view SPL)Topco Allergy Relief Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2010-01-061368000212
27a899a3fd-ba7d-4a59-a53d-85eb154d8335 (view SPL)Drug FactsotcHuman OTCCardinal Healthmanufacture2012-07-241372050745
28abeae0a6-7f41-45e3-b2ae-145a2e633bc7 (view SPL)Drug FactsotcHuman OTCSelect Brandmanufacture2012-10-021151270979
29b681ea25-d00b-4c8a-8054-cc6f983ce337 (view SPL)Claritin RediTabsotcHuman OTCMsd Consumer Care, Inc.2014-09-194115234329, 115237157
30bc253aa7-686c-40e6-affa-a585b465046a (view SPL)Drug FactsotcHuman OTCSupervalu, Incmanufacture2013-12-041411630528
31cf728502-2f76-4e09-b597-979e1dbbf4a6 (view SPL)Target Corporation Allergy Relief Drug FactsotcHuman OTCTarget Corp2009-07-211116730311
32d23d17a0-bdfb-4e5e-b5f2-b4af16e27380 (view SPL)SuperValu Allergy Relief Drug FactsotcHuman OTCSupervalu, Inc2009-07-211411630311
33de3a7725-5d1b-4195-a9f8-43f92888997c (view SPL)Drug FactsotcHuman OTCOhm Laboratories Inc.manufacture2014-04-145516600527
34df4fbe7f-ab04-450f-903d-348b00575036 (view SPL)Drug FactsotcHuman OTCCvsmanufacture2013-06-051597790527
35e2fe073f-14da-424f-a34c-486d666fd649 (view SPL)Drug FactsotcHuman OTCTarget Corpmanufacture2012-10-053116730513, 116730527
36f45af3e4-5dd5-ea0a-c47c-8d68a1249158 (view SPL)Alavert Allergy (Fresh Mint)Alavert Allergy (Citrus Burst)(loratadine)otcHuman OTCPfizer Consumer Healthcare2014-09-257005732620, 005732621

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