Levonorgestrel Oral Tablet

Brand(s)
Aftera, Afterpill, EContra, Fallback Solo, Morning After, My Way, Next Choice One Dose, Opcicon One-Step, Plan B One-Step, Take Action
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Lotus Pharmaceutical Co., Ltd. Nantou Plant (2015-09-02)
Oldest Current Product
2009-07-10
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\LEVONORGESTREL
FDAOB
ORAL\TABLET\LEVONORGESTREL
SPL Active
ORAL\TABLET\LEVONORGESTREL
SPL Moiety
ORAL\TABLET\LEVONORGESTREL

product(s) by strength(s)

levonorgestrel 1.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850146Plan B One-StepNDATeva Women'S Health, Inc.2013-12-12LEVONORGESTRELORALTABLETNDA0219980ce3ccc4-23f2-4e0a-9650-856cf026c72c
2512850942Plan B One-StepNDATeva Women'S Health, Inc.2009-07-282016-09-30LEVONORGESTRELORALTABLETNDA021998a5e522b5-bc59-4010-a658-6e0c0884b234
3512850963Plan B One-StepNDATeva Women'S Health, Inc.2009-09-142016-04-30LEVONORGESTRELORALTABLETNDA021998a5e522b5-bc59-4010-a658-6e0c0884b234

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320620ANDANovel Laboratories, Inc.2013-02-22LEVONORGESTRELORALTABLETANDA202508d0bbb668-cc24-436b-9144-673a28b81f7d
2400320622ANDANovel Laboratories, Inc.2013-02-15LEVONORGESTRELORALTABLETANDA202508ac13a073-a33a-45f7-8483-eecc9190195f
3400510018ANDALotus Pharmaceutical Co., Ltd. Nantou Plant2015-09-01LEVONORGESTRELORALTABLETANDA20224616915c2b-4713-4c23-a622-32e38837b276
4433860620My WayANDAGavis Pharmaceuticals, Llc2013-02-22LEVONORGESTRELORALTABLETANDA202508c749c15a-2c92-4db9-a6b9-fdf18da5b7da
5433860622My WayANDAGavis Pharmaceuticals, Llc2013-02-15LEVONORGESTRELORALTABLETANDA202508ec01077e-ac3c-424a-9edc-0854fe0a2e0d
6501020111EContraANDAAfaxys Inc.2015-01-01LEVONORGESTRELORALTABLETANDA2027395752210e-459b-467c-8fda-b5976c07d88e
7512850100Take ActionNDA AUTHORIZED GENERICTeva Women'S Health, Inc.2014-02-17LEVONORGESTRELORALTABLETNDA02199894f251c1-599c-4517-8c60-50a896b06992
8512850103AfteraNDA AUTHORIZED GENERICTeva Women'S Health, Inc.2014-10-28LEVONORGESTRELORALTABLETNDA02199898f46182-3656-4381-8e2a-88f7fb48c0de
9525440065Next Choice One DoseANDAActavis Pharma, Inc.2014-05-12LEVONORGESTRELORALTABLETANDA200670eb8c1837-d5e5-4ba2-a4b5-8c4f4be029cd
10525440287ANDAActavis Pharma, Inc.2012-07-16LEVONORGESTRELORALTABLETANDA2006700034fc51-706c-4b03-b8f4-6255a329dd9b
11627560718Opcicon One-StepANDASun Pharmaceutical Industries Limited2014-09-12LEVONORGESTRELORALTABLETANDA202635b67ca313-561e-471f-baf3-257b7e253c75
12637040009ANDAPharmacist Pharmaceutical, Llc2013-06-11LEVONORGESTRELORALTABLETANDA2025088abfde83-0ee3-4642-89cf-1d5ff423da31
13637040010ANDAPharmacist Pharmaceutical, Llc2014-03-12LEVONORGESTRELORALTABLETANDA20250820048cf0-9fe6-43f9-8137-4021e5ff910e
14641220604AfterpillANDASyzygy Healthcare Solutions, Llc2013-02-15LEVONORGESTRELORALTABLETANDA202508ca874f63-243f-41f3-b5a1-0e556f3893d1
15681800853Fallback SoloANDALupin Pharmaceuticals, Inc.2014-07-22LEVONORGESTRELORALTABLETANDA20144638c26cb9-052e-426f-9916-c13e7a5e62d0
16699530514Morning AfterANDARapha Pharmaceuticals, Inc.2015-07-01LEVONORGESTRELORALTABLETANDA2025081aeedfda-1686-7500-e054-00144ff88e88

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950973Plan B One-StepNDARebel Distributors Corp2009-07-10LEVONORGESTRELORALTABLET512850942NDA021998e17b3ec0-7739-4775-b7a2-a262f4f3a836

application(s)

#idtitledeprecatedapplicantapprovedexclusivityapproved drug
1ANDA078665LEVONORGESTRELWATSON LABORATORIES INC2009-08-28ANDA078665_001, ANDA078665_001_1
2ANDA078666LEVONORGESTRELTrueWATSON LABORATORIES INC2009-06-24ANDA078666_001
3ANDA090740LEVONORGESTRELPERRIGO R AND D CO2010-12-30ANDA090740_001, ANDA090740_001_1
4ANDA091328LEVONORGESTRELTrueLUPIN LTD2013-01-23ANDA091328_001
5ANDA200670LEVONORGESTRELWATSON LABORATORIES INC2012-07-12ANDA200670_001, ANDA200670_001_1
6ANDA201446FALLBACK SOLOLUPIN LTD2014-06-19ANDA201446_001
7ANDA202246LEVONORGESTRELLOTUS PHARMACEUTICAL CO LTD2015-06-05ANDA202246_001
8ANDA202334LEVONORGESTRELPERRIGO R AND D CO2014-08-20ANDA202334_001
9ANDA202380LEVONORGESTRELOC PHARMA LLC2015-05-29ANDA202380_001
10ANDA202508LEVONORGESTRELNOVEL LABORATORIES INC2013-02-22ANDA202508_001, ANDA202508_001_1
11ANDA202635OPCICON ONE-STEPSUN PHARMACEUTICAL INDUSTRIES LTD2014-09-11ANDA202635_001
12ANDA202739LEVONORGESTRELJAI PHARMA LTD2014-10-31ANDA202739_001
13NDA021045PLAN BTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC1999-07-28NDA021045_001, NDA021045_002, NDA021045_002_1
14NDA021998PLAN B ONE-STEPTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2009-07-10OTC USE FOR WOMEN AGE 14 AND BELOW [2016-04-30]
OTC USE FOR WOMEN AGES 15 AND 16 [2016-04-30]
NDA021998_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078665_001OTCLEVONORGESTREL (0.75MG)ORALTABLETTrue2009-08-28LEVONORGESTREL
2ANDA078665_001_1RXLEVONORGESTREL (0.75MG)ORALTABLETTrueAB2009-08-28LEVONORGESTREL
3ANDA078666_001discontinuedLEVONORGESTREL (0.75MG)ORALTABLETFalse2009-06-24LEVONORGESTREL
4ANDA090740_001RXLEVONORGESTREL (0.75MG)ORALTABLETFalseAB2010-12-30LEVONORGESTREL
5ANDA090740_001_1OTCLEVONORGESTREL (0.75MG)ORALTABLETFalse2010-12-30LEVONORGESTREL
6ANDA091328_001discontinuedLEVONORGESTREL (0.75MG)ORALTABLETFalse2013-01-23LEVONORGESTREL
7ANDA200670_001RXLEVONORGESTREL (1.5MG)ORALTABLETFalseAB2012-07-12LEVONORGESTREL
8ANDA200670_001_1OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2012-07-12LEVONORGESTREL
9ANDA201446_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2014-06-19FALLBACK SOLO
10ANDA202246_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2015-06-05LEVONORGESTREL
11ANDA202334_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2014-08-20LEVONORGESTREL
12ANDA202380_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2015-05-29LEVONORGESTREL
13ANDA202508_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2013-02-22LEVONORGESTREL
14ANDA202508_001_1RXLEVONORGESTREL (1.5MG)ORALTABLETFalseAB2013-02-22LEVONORGESTREL
15ANDA202635_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2014-09-11OPCICON ONE-STEP
16ANDA202739_001OTCLEVONORGESTREL (1.5MG)ORALTABLETFalse2014-10-31LEVONORGESTREL
17NDA021045_001discontinuedLEVONORGESTREL (0.75MG)ORALTABLETFalse1999-07-28PLAN B
18NDA021045_002OTCLEVONORGESTREL (0.75MG)ORALTABLETTrue2006-08-24PLAN B
19NDA021045_002_1RXLEVONORGESTREL (0.75MG)ORALTABLETTrueAB2006-08-24PLAN B
20NDA021998_001OTCLEVONORGESTREL (1.5MG)ORALTABLETTrue2009-07-10PLAN B ONE-STEP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10034fc51-706c-4b03-b8f4-6255a329dd9b (view SPL)These highlights do not include all the information needed to useNext Choice One DoseTMsafely and effectively. See full prescribing information for Next Choice One DoseTM . Next Choice One Dose TM (Levonorgestrel) TABLET, 1.5 mg, for ORAL use Initial U.S. Approval: 1982prescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-12-0611525440287
20ce3ccc4-23f2-4e0a-9650-856cf026c72c (view SPL)Plan B One-StepotcHuman OTCTeva Women'S Health, Inc.2013-12-122512850146, 512850124
316915c2b-4713-4c23-a622-32e38837b276 (view SPL)Drug FactsotcHuman OTCLotus Pharmaceutical Co., Ltd. Nantou PlantANALYSIS, LABEL, MANUFACTURE2015-09-022400510018
41aeedfda-1686-7500-e054-00144ff88e88 (view SPL)otcHuman OTCRapha Pharmaceuticals, Inc.2015-07-151699530514
520048cf0-9fe6-43f9-8137-4021e5ff910e (view SPL)Drug FactsotcHuman OTCPharmacist Pharmaceutical, LlcMANUFACTURE2014-04-151637040010
638c26cb9-052e-426f-9916-c13e7a5e62d0 (view SPL)Fallback Solo(levonorgestrel) Tablet, 1.5 mgotcHuman OTCLupin Pharmaceuticals, Inc.Manufacture2014-07-223681800853
75752210e-459b-467c-8fda-b5976c07d88e (view SPL)EContra EZ(Levonorgestrel) Tablet, 1.5 mgotcHuman OTCAfaxys Inc.analysis, label, manufacture, pack2015-08-282501020111
88abfde83-0ee3-4642-89cf-1d5ff423da31 (view SPL)These highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use.Initial U.S. Approval: 1982prescriptionHuman PrescriptionPharmacist Pharmaceutical, LlcMANUFACTURE2013-07-291637040009
994f251c1-599c-4517-8c60-50a896b06992 (view SPL)take actionTMotcHuman OTCTeva Women'S Health, Inc.2014-02-281512850100
1098f46182-3656-4381-8e2a-88f7fb48c0de (view SPL)AfteraDrug FactsotcHuman OTCTeva Women'S Health, Inc.2015-01-081512850103
11a5e522b5-bc59-4010-a658-6e0c0884b234 (view SPL)These highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 1982prescriptionHuman PrescriptionTeva Women'S Health, Inc.2013-11-216512850942, 512850963
12ac13a073-a33a-45f7-8483-eecc9190195f (view SPL)Drug FactsprescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2014-02-262400320622
13b67ca313-561e-471f-baf3-257b7e253c75 (view SPL)Opcicon One-StepotcHuman OTCSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2014-09-123627560718
14c749c15a-2c92-4db9-a6b9-fdf18da5b7da (view SPL)These highlights do not include all the information needed to use My Way safely and effectively. See full prescribing information for My Way. My Way (Levonorgestrel) TABLET for ORAL use.Initial U.S. Approval: 1982prescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-02-271433860620
15ca874f63-243f-41f3-b5a1-0e556f3893d1 (view SPL)Drug FactsotcHuman OTCSyzygy Healthcare Solutions, Llc2014-08-131641220604
16d0bbb668-cc24-436b-9144-673a28b81f7d (view SPL)These highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use.Initial U.S. Approval: 1982prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2013-02-262400320620
17d6326ec1-b497-490b-915e-ed70df4b6e48 (view SPL)Plan B One-Step Emergency ContraceptiveOne Tablet. One Step.What You Need to KnowotcHuman OTCTeva Women'S Health, Inc.2013-11-192512850943
18e17b3ec0-7739-4775-b7a2-a262f4f3a836 (view SPL)These highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 1982prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-09-131216950973
19e53e3f9a-d359-4c5a-aceb-d002ed367849 (view SPL)Plan B One-StepotcHuman OTCTeva Women'S Health, Inc.2013-12-062512850162
20eb8c1837-d5e5-4ba2-a4b5-8c4f4be029cd (view SPL)Next Choice - One Dose (Levonorgestrel) Tablet 1.5 mgotcHuman OTCActavis Pharma, Inc.2014-04-211525440065
21ec01077e-ac3c-424a-9edc-0854fe0a2e0d (view SPL)Drug FactsotcHuman OTCGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2014-05-052433860622

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