Cyproheptadine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-04-28)
Oldest Current Product
2003-05-21
License(s)
ANDA, EXPORT ONLY
RxNORM
ORAL TABLET\CYPROHEPTADINE
FDAOB
ORAL\TABLET\CYPROHEPTADINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\CYPROHEPTADINE
ORAL\TABLET\CYPROHEPTADINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\CYPROHEPTADINE

product(s) by strength(s)

cyproheptadine hydrochloride 4 mg oral tablet

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1620330346EXPORT ONLYBoscogen, Inc.2010-06-15CYPROHEPTADINE HYDROCHLORIDEORALTABLETf90faaa3-f40f-4653-8fb8-144d61c6b1d4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932929ANDATeva Pharmaceuticals Usa Inc2009-01-23CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA08705621c25efc-9230-4c62-97d1-a465b12d6638
2004636080ANDAC.O. Truxton, Inc.2010-06-15CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA040644a071c63a-1162-4c1b-a73e-26068e0e9542
3507420190ANDAIngenus Pharmaceuticals, Llc2015-09-23CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA20508756f428c9-8d33-4c91-91d8-1fe194335066
4519910838ANDABreckenridge Pharmaceutical, Inc.2013-10-21CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA04064483176be9-c493-4904-90eb-1a8573194a7c
5526820049ANDAMirror Pharmaceuticals Llc2015-09-23CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA205087a8481bfa-c4b5-418d-b1f8-381b3d744d6d
6647200150ANDACorepharma, Llc2015-07-29CYPROHEPTADINE HYDROCHLORIDEORALTABLETANDA0405378aa0e888-3e56-41f1-9305-03dc4fb18571

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151536ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-01-08CYPROHEPTADINE HYDROCHLORIDEORALTABLET000932929ANDA0870568d2bd313-3ab3-4fed-81d6-d2d81edcb206
2422910225ANDAAvkare, Inc.2010-06-15CYPROHEPTADINE HYDROCHLORIDEORALTABLET519910838ANDA040644b9e618d2-1178-d8e3-5479-8442b41ed8ff
3493490530ANDARemedyrepack Inc.2011-09-22CYPROHEPTADINE HYDROCHLORIDEORALTABLET649800123ANDA0405378e6aeba2-eb3d-4eb6-871e-44de0133735e
4493490781ANDARemedyrepack Inc.2011-09-20CYPROHEPTADINE HYDROCHLORIDEORALTABLET602580850ANDA040644e1745c6f-e11a-482c-a762-a77ed63bcb1d
5521250014ANDARemedyrepack Inc.2012-08-16CYPROHEPTADINEORALTABLET000932929ANDA08705612cf01c7-bb0b-47db-8401-fd43d8dce1ff
6521250796ANDARemedyrepack Inc.2013-12-31CYPROHEPTADINE HYDROCHLORIDEORALTABLET602580850ANDA040644be96367b-a530-41da-a1ba-04a183310f9c
7538080829ANDAState Of Florida Doh Central Pharmacy2013-01-01CYPROHEPTADINE HYDROCHLORIDEORALTABLET000932929ANDA087056ac29ea30-ab15-4123-9f5d-7bf5becc66e8
8538080950ANDAState Of Florida Doh Central Pharmacy2009-07-01CYPROHEPTADINE HYDROCHLORIDEORALTABLET649800123ANDA040537355d65a6-0681-475f-beb7-42980ec5ece5
9538081030ANDAState Of Florida Doh Central Pharmacy2014-11-01CYPROHEPTADINE HYDROCHLORIDEORALTABLET000932929ANDA0870569ffed85f-8c9f-49d3-8703-89ed9d2f1eec
10548681332ANDAPhysicians Total Care, Inc.2003-05-21CYPROHEPTADINE HYDROCHLORIDEORALTABLET649800123ANDA04053776f11fdd-6089-47a1-b1a1-ee1bf490dc97
11551543255ANDACardinal Health2010-06-15CYPROHEPTADINE HYDROCHLORIDEORALTABLET602580850ANDA0406446094fad5-cd32-4352-a837-a99d9c6ec7f1
12636292982ANDABryant Ranch Prepack2009-01-23CYPROHEPTADINE HYDROCHLORIDEORALTABLET000932929ANDA087056f4efb1a2-2b88-45d0-9de8-e92ea7046362
13681512506ANDACarilion Materials Management2010-06-15CYPROHEPTADINE HYDROCHLORIDEORALTABLET602580850ANDA04064447625688-0684-4c63-945d-9398da43a4fc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040537CYPROHEPTADINE HYDROCHLORIDECOREPHARMA LLC2003-09-30ANDA040537_001
2ANDA040644CYPROHEPTADINE HYDROCHLORIDESTASON PHARMACEUTICALS INC2006-05-30ANDA040644_001
3ANDA085245CYPROHEPTADINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085245_001
4ANDA086165CYPROHEPTADINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA086165_001
5ANDA086580CYPROHEPTADINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA086580_001
6ANDA086678CYPROHEPTADINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INCANDA086678_001
7ANDA086737CYPROHEPTADINE HYDROCHLORIDETrueKV PHARMACEUTICAL COANDA086737_001
8ANDA086808CYPROHEPTADINE HYDROCHLORIDETrueSANDOZ INCANDA086808_001
9ANDA087056CYPROHEPTADINE HYDROCHLORIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA087056_001
10ANDA087129CYPROHEPTADINE HYDROCHLORIDEPAR PHARMACEUTICAL INCANDA087129_001
11ANDA087284CYPROHEPTADINE HYDROCHLORIDETrueVITARINE PHARMACEUTICALS INCANDA087284_001
12ANDA087405CYPROHEPTADINE HYDROCHLORIDETrueSUPERPHARM CORPANDA087405_001
13ANDA087566CYPROHEPTADINE HYDROCHLORIDETrueMD PHARMACEUTICAL INC1982-11-10ANDA087566_001
14ANDA087685CYPROHEPTADINE HYDROCHLORIDETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1982-10-25ANDA087685_001
15ANDA087839CYPROHEPTADINE HYDROCHLORIDETruePIONEER PHARMACEUTICALS INC1984-02-08ANDA087839_001
16ANDA088205CYPROHEPTADINE HYDROCHLORIDETruePLIVA INC1983-07-26ANDA088205_001
17ANDA088212CYPROHEPTADINE HYDROCHLORIDETrueTG UNITED LABS LLC1983-05-26ANDA088212_001
18ANDA088232CYPROHEPTADINE HYDROCHLORIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1983-10-25ANDA088232_001
19ANDA088798CYPROHEPTADINE HYDROCHLORIDETrueAMERICAN THERAPEUTICS INC1985-02-15ANDA088798_001
20ANDA089057CYPROHEPTADINE HYDROCHLORIDETrueHALSEY DRUG CO INC1986-07-03ANDA089057_001
21ANDA205087CYPROHEPTADINE HYDROCHLORIDEMIRROR PHARMACEUTICALS LLC2015-09-23ANDA205087_001
22NDA012649PERIACTINTrueMERCK AND CO INCNDA012649_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040537_001RXCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseAA2003-09-30CYPROHEPTADINE HYDROCHLORIDE
2ANDA040644_001RXCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseAA2006-05-30CYPROHEPTADINE HYDROCHLORIDE
3ANDA085245_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
4ANDA086165_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
5ANDA086580_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
6ANDA086678_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
7ANDA086737_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
8ANDA086808_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
9ANDA087056_001RXCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETTrueAACYPROHEPTADINE HYDROCHLORIDE
10ANDA087129_001RXCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseAACYPROHEPTADINE HYDROCHLORIDE
11ANDA087284_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
12ANDA087405_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseCYPROHEPTADINE HYDROCHLORIDE
13ANDA087566_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1982-11-10CYPROHEPTADINE HYDROCHLORIDE
14ANDA087685_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1982-10-25CYPROHEPTADINE HYDROCHLORIDE
15ANDA087839_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1984-02-08CYPROHEPTADINE HYDROCHLORIDE
16ANDA088205_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1983-07-26CYPROHEPTADINE HYDROCHLORIDE
17ANDA088212_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1983-05-26CYPROHEPTADINE HYDROCHLORIDE
18ANDA088232_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1983-10-25CYPROHEPTADINE HYDROCHLORIDE
19ANDA088798_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1985-02-15CYPROHEPTADINE HYDROCHLORIDE
20ANDA089057_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalse1986-07-03CYPROHEPTADINE HYDROCHLORIDE
21ANDA205087_001RXCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalseAA2015-09-23CYPROHEPTADINE HYDROCHLORIDE
22NDA012649_001discontinuedCYPROHEPTADINE HYDROCHLORIDE (4MG)ORALTABLETFalsePERIACTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112cf01c7-bb0b-47db-8401-fd43d8dce1ff (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-08-161521250014
221c25efc-9230-4c62-97d1-a465b12d6638 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-04-283000932929
3355d65a6-0681-475f-beb7-42980ec5ece5 (view SPL)Cyproheptadine Hydrochloride Tablets USPRx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080950
447625688-0684-4c63-945d-9398da43a4fc (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP Rx OnlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-07-202681512506
556f428c9-8d33-4c91-91d8-1fe194335066 (view SPL)CYPROHEPTADINEHYDROCHLORIDETABLETS, USPRx onlyprescriptionHuman PrescriptionIngenus Pharmaceuticals, Llcanalysis, manufacture, pack2015-10-051507420190
66094fad5-cd32-4352-a837-a99d9c6ec7f1 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP Rx OnlyprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-152551543255
776f11fdd-6089-47a1-b1a1-ee1bf490dc97 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-12-302548681332
883176be9-c493-4904-90eb-1a8573194a7c (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2013-10-101519910838
98aa0e888-3e56-41f1-9305-03dc4fb18571 (view SPL)Cyproheptadine Hydrochloride Tablets, USPRx onlyprescriptionHuman PrescriptionCorepharma, Llc2015-07-303647200150
108d2bd313-3ab3-4fed-81d6-d2d81edcb206 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-12-043006151536
118e6aeba2-eb3d-4eb6-871e-44de0133735e (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-221493490530
129ffed85f-8c9f-49d3-8703-89ed9d2f1eec (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2015-01-031538081030
13a071c63a-1162-4c1b-a73e-26068e0e9542 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP Rx OnlyprescriptionHuman PrescriptionC.O. Truxton, Inc.manufacture2014-04-301004636080
14a8481bfa-c4b5-418d-b1f8-381b3d744d6d (view SPL)CYPROHEPTADINEHYDROCHLORIDETABLETS, USPRx onlyprescriptionHuman PrescriptionMirror Pharmaceuticals Llcmanufacture2015-10-053526820049
15ac29ea30-ab15-4123-9f5d-7bf5becc66e8 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx onlyprescriptionHuman PrescriptionState Of Florida Doh Central PharmacyMANUFACTURE2013-09-091538080829
16b9e618d2-1178-d8e3-5479-8442b41ed8ff (view SPL)cyproheptadine hydrochlorideprescriptionHuman PrescriptionAvkare, Inc.2013-07-014422910225
17be96367b-a530-41da-a1ba-04a183310f9c (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP Rx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-311521250796
18e1745c6f-e11a-482c-a762-a77ed63bcb1d (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-201493490781
19f4efb1a2-2b88-45d0-9de8-e92ea7046362 (view SPL)CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-05-171000636292982
20f90faaa3-f40f-4653-8fb8-144d61c6b1d4 (view SPL)Cyproheptadine Hydrochloride TabletsprescriptionHuman PrescriptionBoscogen, Inc.4620330346

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