Amoxicillin Chewable Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-11-13)
Oldest Current Product
1993-01-01
License(s)
ANDA
RxNORM
CHEWABLE TABLET\AMOXICILLIN
FDAOB
ORAL\TABLET, CHEWABLE\AMOXICILLIN
SPL Active
ORAL\TABLET, CHEWABLE\AMOXICILLIN
ORAL\TABLET\AMOXICILLIN
SPL Moiety
ORAL\TABLET, CHEWABLE\AMOXICILLIN
ORAL\TABLET, CHEWABLE\AMOXICILLIN ANHYDROUS
ORAL\TABLET\AMOXICILLIN

product(s) by strength(s)

amoxicillin 125 mg chewable tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932267ANDATeva Pharmaceuticals Usa Inc1995-10-01AMOXICILLINORALTABLET, CHEWABLEANDA0640134c0f348a-a65d-409c-8668-207c82a5e3cb

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530151ANDADava Pharmaceuticals, Inc.1996-01-29AMOXICILLINORALTABLET, CHEWABLEANDA0641395d22f9b8-3022-42e8-a427-fc43c589c92c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900647ANDAStat Rx Usa Llc2010-01-28AMOXICILLINORALTABLET, CHEWABLE000932267ANDA064013269fa5f9-974e-4cea-8f6b-a2913a6dc1cb

amoxicillin 250 mg chewable tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932268ANDATeva Pharmaceuticals Usa Inc1993-01-01AMOXICILLINORALTABLET, CHEWABLEANDA0640134c0f348a-a65d-409c-8668-207c82a5e3cb

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530152ANDADava Pharmaceuticals, Inc.1996-01-29AMOXICILLINORALTABLET, CHEWABLEANDA0641395d22f9b8-3022-42e8-a427-fc43c589c92c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440165ANDABlenheim Pharmacal, Inc.2013-11-15AMOXICILLINORALTABLET, CHEWABLE000932268ANDA064013e91786c4-f928-4419-bd57-eca11498a6e6
2216950418ANDARebel Distributors Corp2010-01-28AMOXICILLINORALTABLET000932268ANDA064013432287dc-6d16-4a64-bc5f-ec1327104f7e
3430630341ANDAPd-Rx Pharmaceuticals, Inc.2011-11-18AMOXICILLINORALTABLET, CHEWABLE000932268ANDA06401309660a95-a7b3-4d1f-832c-a4fa7a5b7ddd
4545693689ANDAA-S Medication Solutions Llc1993-01-01AMOXICILLINORALTABLET, CHEWABLE000932268ANDA06401314705eff-f5b8-4c79-b5fd-a999399248f0
5548683105ANDAPhysicians Total Care, Inc.2004-06-01AMOXICILLINORALTABLET, CHEWABLE633040515ANDA065021afbcbf79-e7cd-4615-a999-9941573882b5
6552890182ANDAPd-Rx Pharmaceuticals, Inc.2010-01-28AMOXICILLINORALTABLET, CHEWABLE000932268ANDA06401398e9274c-c02e-44d9-8cc5-17536ef03a77
7631870343ANDAProficient Rx Lp1993-01-01AMOXICILLINORALTABLET, CHEWABLE000932268ANDA06401352e676e4-b70e-4e73-bbe7-f54d91ca7e0a

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684614ANDAPhysicians Total Care, Inc.2007-02-142010-06-30AMOXICILLINORALTABLET, CHEWABLE633040761ANDA065060afbcbf79-e7cd-4615-a999-9941573882b5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA064013AMOXICILLINTEVA PHARMACEUTICALS USA INC1992-12-22ANDA064013_001, ANDA064013_002
2ANDA064031AMOXICILLINTrueTEVA PHARMACEUTICALS USA INC1996-12-19ANDA064031_001, ANDA064031_002
3ANDA064131AMOXICILLINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1996-05-06ANDA064131_001, ANDA064131_002
4ANDA064139AMOXICILLINTrueDAVA PHARMACEUTICALS INC1996-01-29ANDA064139_001, ANDA064139_002
5ANDA065021AMOXICILLINSUN PHARMACEUTICAL INDUSTRIES LTD1999-12-23ANDA065021_001, ANDA065021_002
6ANDA065060AMOXICILLINTrueSUN PHARMACEUTICAL INDUSTRIES LTD2000-11-29ANDA065060_001, ANDA065060_002
7NDA050542AMOXILDR REDDYS LABORATORIES INCNDA050542_001, NDA050542_002
8NDA050761AMOXILTrueDR REDDYS LABORATORIES INC1999-04-15NDA050761_001, NDA050761_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA064013_001RXAMOXICILLIN (250MG)ORALTABLET, CHEWABLETrueAB1992-12-22AMOXICILLIN
2ANDA064013_002RXAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalseAB1995-09-11AMOXICILLIN
3ANDA064031_001discontinuedAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalse1996-12-19AMOXICILLIN
4ANDA064031_002discontinuedAMOXICILLIN (250MG)ORALTABLET, CHEWABLEFalse1996-12-19AMOXICILLIN
5ANDA064131_001discontinuedAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalse1996-05-06AMOXICILLIN
6ANDA064131_002discontinuedAMOXICILLIN (250MG)ORALTABLET, CHEWABLEFalse1996-05-06AMOXICILLIN
7ANDA064139_001discontinuedAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalse1996-01-29AMOXICILLIN
8ANDA064139_002discontinuedAMOXICILLIN (250MG)ORALTABLET, CHEWABLEFalse1996-01-29AMOXICILLIN
9ANDA065021_001RXAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalseAB1999-12-23AMOXICILLIN
10ANDA065021_002RXAMOXICILLIN (250MG)ORALTABLET, CHEWABLEFalseAB1999-12-23AMOXICILLIN
11ANDA065060_001discontinuedAMOXICILLIN (200MG)ORALTABLET, CHEWABLEFalse2000-11-29AMOXICILLIN
12ANDA065060_002discontinuedAMOXICILLIN (400MG)ORALTABLET, CHEWABLEFalse2000-11-29AMOXICILLIN
13NDA050542_001RXAMOXICILLIN (250MG)ORALTABLET, CHEWABLEFalseABAMOXIL
14NDA050542_002RXAMOXICILLIN (125MG)ORALTABLET, CHEWABLEFalseABAMOXIL
15NDA050761_001discontinuedAMOXICILLIN (200MG)ORALTABLET, CHEWABLEFalse1999-04-15AMOXIL
16NDA050761_002discontinuedAMOXICILLIN (400MG)ORALTABLET, CHEWABLEFalse1999-04-15AMOXIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
109660a95-a7b3-4d1f-832c-a4fa7a5b7ddd (view SPL)AMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg310731094150415522672268Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-11-275430630341
214705eff-f5b8-4c79-b5fd-a999399248f0 (view SPL)These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel, repack2013-06-201545693689, 545692929Amoxicillin Oral Suspension
3269fa5f9-974e-4cea-8f6b-a2913a6dc1cb (view SPL)AMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg310731092267226841504155Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llc2010-03-221165900647
4432287dc-6d16-4a64-bc5f-ec1327104f7e (view SPL)AMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg310731092267226841504155Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-081216950418
54c0f348a-a65d-409c-8668-207c82a5e3cb (view SPL)These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral useInitial U.S. Approval: 1974prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-1315000932267, 000932268, 000933107, 000933109, 000934150, 000934155Amoxicillin Oral Suspension
Amoxicillin Oral Capsule
652e676e4-b70e-4e73-bbe7-f54d91ca7e0a (view SPL)These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870343
75d22f9b8-3022-42e8-a427-fc43c589c92c (view SPL)AMOXICILLIN CAPSULES, USP 250 mg and 500 mg AMOXICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL AMOXICILLIN TABLETS, USP 875 mg AMOXICILLIN TABLETS, USP (CHEWABLE) 125 mg and 250 mg Rx onlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-012672530151, 672530152, 672530140, 672530141, 672530142, 672530143, 672530145Amoxicillin Oral Suspension
Amoxicillin Oral Tablet
Amoxicillin Oral Capsule
898e9274c-c02e-44d9-8cc5-17536ef03a77 (view SPL)AMOXICILLIN CAPSULES USP, 250 mg Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-065552890182
9afbcbf79-e7cd-4615-a999-9941573882b5 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-10-192548683105, 548684614
10e91786c4-f928-4419-bd57-eca11498a6e6 (view SPL)These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-07-313105440165

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