Ampicillin Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2015-08-06)
Oldest Current Product
1989-02-10
License(s)
ANDA
RxNORM
ORAL SUSPENSION\AMPICILLIN
FDAOB
ORAL\FOR SUSPENSION\AMPICILLIN/AMPICILLIN TRIHYDRATE
SPL Active
ORAL\SUSPENSION\AMPICILLIN TRIHYDRATE
SPL Moiety
ORAL\SUSPENSION\AMPICILLIN

product(s) by strength(s)

ampicillin 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530182ANDADava Pharmaceuticals, Inc.1989-02-10AMPICILLIN TRIHYDRATEORALSUSPENSIONANDA0629821422ac93-067c-489b-9b95-17cd00303f4c, 4dd38d9b-c5cf-450a-8c78-0ba312bdbf6f

ampicillin 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530183ANDADava Pharmaceuticals, Inc.1989-02-10AMPICILLIN TRIHYDRATEORALSUSPENSIONANDA0629821422ac93-067c-489b-9b95-17cd00303f4c, 4dd38d9b-c5cf-450a-8c78-0ba312bdbf6f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060127PRINCIPEN '125'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB COANDA060127_001, ANDA060127_002
2ANDA060625OMNIPEN (AMPICILLIN)TrueWYETH AYERST LABORATORIESANDA060625_001, ANDA060625_002, ANDA060625_003, ANDA060625_004
3ANDA060666TOTACILLINTrueGLAXOSMITHKLINEANDA060666_001, ANDA060666_002
4ANDA061370AMPICILLIN TRIHYDRATETrueTEVA PHARMACEUTICALS USA INCANDA061370_001, ANDA061370_002
5ANDA061394PRINCIPENTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA061394_001, ANDA061394_002, ANDA061394_003
6ANDA061601AMPICILLIN TRIHYDRATETrueAMERICAN ANTIBIOTICS LLCANDA061601_001, ANDA061601_002
7ANDA061829AMPICILLIN TRIHYDRATETrueMYLAN PHARMACEUTICALS INCANDA061829_001, ANDA061829_002
8ANDA061980AMPICILLIN TRIHYDRATETruePUREPAC PHARMACEUTICAL COANDA061980_001, ANDA061980_002
9ANDA062030AMCILLTruePARKE DAVIS DIV WARNER LAMBERT COANDA062030_001, ANDA062030_002
10ANDA062049PFIZERPEN-ATruePFIZER LABORATORIES DIV PFIZER INCANDA062049_001, ANDA062049_002
11ANDA062151PRINCIPEN '125'TrueAPOTHECON SUB BRISTOL MYERS SQUIBB COANDA062151_001, ANDA062151_002
12ANDA062223TOTACILLINTrueGLAXOSMITHKLINEANDA062223_001, ANDA062223_002
13ANDA062297POLYCILLINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA062297_001, ANDA062297_002
14ANDA062982AMPICILLIN TRIHYDRATEDAVA PHARMACEUTICALS INC1989-02-10ANDA062982_001, ANDA062982_002
15NDA050019PENBRITINTrueWYETH AYERST LABORATORIESNDA050019_001, NDA050019_002, NDA050019_003
16NDA050308POLYCILLINTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CONDA050308_001, NDA050308_002, NDA050308_003, NDA050308_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA060127_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN '125'
2ANDA060127_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN '125'
3ANDA060625_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (100MG/ML)ORALFOR SUSPENSIONFalseOMNIPEN (AMPICILLIN)
4ANDA060625_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (125MG/5ML)ORALFOR SUSPENSIONFalseOMNIPEN (AMPICILLIN)
5ANDA060625_003discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (250MG/5ML)ORALFOR SUSPENSIONFalseOMNIPEN (AMPICILLIN)
6ANDA060625_004discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (500MG/5ML)ORALFOR SUSPENSIONFalseOMNIPEN (AMPICILLIN)
7ANDA060666_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseTOTACILLIN
8ANDA060666_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseTOTACILLIN
9ANDA061370_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
10ANDA061370_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
11ANDA061394_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 100MG BASE/ML)ORALFOR SUSPENSIONFalsePRINCIPEN
12ANDA061394_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN
13ANDA061394_003discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN
14ANDA061601_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
15ANDA061601_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
16ANDA061829_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
17ANDA061829_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
18ANDA061980_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
19ANDA061980_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAMPICILLIN TRIHYDRATE
20ANDA062030_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAMCILL
21ANDA062030_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAMCILL
22ANDA062049_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePFIZERPEN-A
23ANDA062049_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePFIZERPEN-A
24ANDA062151_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN '125'
25ANDA062151_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePRINCIPEN '125'
26ANDA062223_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseTOTACILLIN
27ANDA062223_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseTOTACILLIN
28ANDA062297_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePOLYCILLIN
29ANDA062297_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePOLYCILLIN
30ANDA062982_001RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1989-02-10AMPICILLIN TRIHYDRATE
31ANDA062982_002RXAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONTrue1989-02-10AMPICILLIN TRIHYDRATE
32NDA050019_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 100MG BASE/ML)ORALFOR SUSPENSIONFalsePENBRITIN
33NDA050019_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePENBRITIN
34NDA050019_003discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePENBRITIN
35NDA050308_001discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalsePOLYCILLIN
36NDA050308_002discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalsePOLYCILLIN
37NDA050308_003discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 500MG BASE/5ML)ORALFOR SUSPENSIONFalsePOLYCILLIN
38NDA050308_004discontinuedAMPICILLIN/AMPICILLIN TRIHYDRATE (EQ 100MG BASE/ML)ORALFOR SUSPENSIONFalsePOLYCILLIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11422ac93-067c-489b-9b95-17cd00303f4c (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mgAMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLRx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE, PACK2015-08-064672530182, 672530183, 672530180, 672530181Ampicillin Oral Capsule
24dd38d9b-c5cf-450a-8c78-0ba312bdbf6f (view SPL)AMPICILLIN CAPSULES, USP 250 mg and 500 mgAMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mLRx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2006-06-011672530182, 672530183

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