prednisolone Oral Tablet

Brand(s)
MILLIPRED
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Zylera Pharmaceuticals, Llc (2014-03-11)
Oldest Current Product
2008-10-01
License(s)
ANDA
RxNORM
ORAL TABLET\PREDNISOLONE
FDAOB
ORAL\TABLET\PREDNISOLONE
SPL Active
ORAL\TABLET\PREDNISOLONE
SPL Moiety
ORAL\TABLET\PREDNISOLONE

product(s) by strength(s)

prednisolone 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1164770505MILLIPREDANDALaser Pharmaceuticals, Llc2008-10-01PREDNISOLONEORALTABLETANDA080354b8fadaec-9985-4f17-9b2f-b2f6a28cae1c
2235940505MILLIPREDANDAZylera Pharmaceuticals, Llc2014-03-01PREDNISOLONEORALTABLETANDA080354863ad743-eec0-46f0-beba-c1556384c636

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080211PREDNISOLONETruePRIVATE FORMULATIONS INCANDA080211_001
2ANDA080236PREDNISOLONETrueVALEANT PHARMACEUTICALS INTERNATIONALANDA080236_001
3ANDA080304CORTALONETrueHALSEY DRUG CO INCANDA080304_001, ANDA080304_002, ANDA080304_003
4ANDA080307PREDNISOLONETrueMARSHALL PHARMACAL CORPANDA080307_001
5ANDA080322PREDNISOLONETruePHOENIX LABORATORIES INCANDA080322_001
6ANDA080324PREDNISOLONETrueWEST WARD PHARMACEUTICAL CORPANDA080324_001
7ANDA080325PREDNISOLONETruePUREPAC PHARMACEUTICAL COANDA080325_001
8ANDA080326PREDNISOLONETrueHEATHER DRUG CO INCANDA080326_001
9ANDA080327PREDNISOLONETrueROXANE LABORATORIES INCANDA080327_002
10ANDA080339PREDNISOLONETrueSANDOZ INCANDA080339_001
11ANDA080342PREDNISOLONETrueWHITEWORTH TOWNE PAULSEN INCANDA080342_001
12ANDA080351PREDNISOLONETruePANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INCANDA080351_001, ANDA080351_002
13ANDA080354PREDNISOLONEWATSON LABORATORIES INCANDA080354_001
14ANDA080358PREDNISOLONETrueSPERTI DRUG PRODUCTS INCANDA080358_001, ANDA080358_002, ANDA080358_003
15ANDA080378PREDNISOLONETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA080378_001
16ANDA080398PREDNISOLONETrueTEVA PHARMACEUTICALS USA INCANDA080398_001
17ANDA080531PREDNISOLONETrueLANNETT CO INCANDA080531_002
18ANDA080534PREDNISOLONETrueVITARINE PHARMACEUTICALS INCANDA080534_001
19ANDA080562PREDNISOLONETrueJOHN J FERRANTEANDA080562_001, ANDA080562_002
20ANDA080625PREDNISOLONETrueELKINS SINN DIV AH ROBINS CO INCANDA080625_001
21ANDA080748PREDNISOLONETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCANDA080748_001
22ANDA080780PREDNISOLONETrueIMPAX LABORATORIES INCANDA080780_001
23ANDA083675PREDNISOLONETrueCM BUNDY COANDA083675_001
24ANDA083941FERNISOLONE-PTrueFERNDALE LABORATORIES INCANDA083941_001
25ANDA084426PREDNISOLONETrueBARR LABORATORIES INCANDA084426_002
26ANDA084439PREDNISOLONETrueEVERYLIFEANDA084439_001, ANDA084439_002, ANDA084439_003
27ANDA084542PREDNISOLONETrueL PERRIGO COANDA084542_001
28ANDA084773PREDNISOLONETrueSANDOZ INCANDA084773_001
29ANDA085085PREDNISOLONETrueWATSON LABORATORIES INCANDA085085_002
30ANDA085170PREDNISOLONETrueTABLICAPS INCANDA085170_001
31ANDA085415PREDNISOLONETrueWATSON LABORATORIES INCANDA085415_001
32ANDA085416PREDNISOLONETrueWATSON LABORATORIES INCANDA085416_001
33ANDA087987PREDNISOLONETrueUDL LABORATORIES INC1983-01-18ANDA087987_001
34ANDA088892PREDNISOLONETrueSUPERPHARM CORP1985-02-26ANDA088892_001
35NDA009987DELTA-CORTEFTruePHARMACIA AND UPJOHN CONDA009987_004
36NDA009996STERANETruePFIZER LABORATORIES DIV PFIZER INCNDA009996_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA080211_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
2ANDA080236_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
3ANDA080304_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalseCORTALONE
4ANDA080304_002discontinuedPREDNISOLONE (2.5MG)ORALTABLETFalseCORTALONE
5ANDA080304_003discontinuedPREDNISOLONE (1MG)ORALTABLETFalseCORTALONE
6ANDA080307_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
7ANDA080322_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
8ANDA080324_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
9ANDA080325_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
10ANDA080326_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
11ANDA080327_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
12ANDA080339_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
13ANDA080342_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
14ANDA080351_001discontinuedPREDNISOLONE (1MG)ORALTABLETFalsePREDNISOLONE
15ANDA080351_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
16ANDA080354_001RXPREDNISOLONE (5MG)ORALTABLETTruePREDNISOLONE
17ANDA080358_001discontinuedPREDNISOLONE (1MG)ORALTABLETFalsePREDNISOLONE
18ANDA080358_002discontinuedPREDNISOLONE (2.5MG)ORALTABLETFalsePREDNISOLONE
19ANDA080358_003discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
20ANDA080378_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
21ANDA080398_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
22ANDA080531_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
23ANDA080534_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
24ANDA080562_001discontinuedPREDNISOLONE (2.5MG)ORALTABLETFalsePREDNISOLONE
25ANDA080562_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
26ANDA080625_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
27ANDA080748_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
28ANDA080780_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
29ANDA083675_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
30ANDA083941_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalseFERNISOLONE-P
31ANDA084426_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
32ANDA084439_001discontinuedPREDNISOLONE (1MG)ORALTABLETFalsePREDNISOLONE
33ANDA084439_002discontinuedPREDNISOLONE (2.5MG)ORALTABLETFalsePREDNISOLONE
34ANDA084439_003discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
35ANDA084542_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
36ANDA084773_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
37ANDA085085_002discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
38ANDA085170_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
39ANDA085415_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
40ANDA085416_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalsePREDNISOLONE
41ANDA087987_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalse1983-01-18PREDNISOLONE
42ANDA088892_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalse1985-02-26PREDNISOLONE
43NDA009987_004discontinuedPREDNISOLONE (5MG)ORALTABLETFalseDELTA-CORTEF
44NDA009996_001discontinuedPREDNISOLONE (5MG)ORALTABLETFalseSTERANE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1863ad743-eec0-46f0-beba-c1556384c636 (view SPL)MILLIPRED (prednisolone tablets USP, 5 mg) MILLIPREDDP - 6-Day TabletDose Pack (prednisolone tablets USP, 5 mg) MILLIPREDDP - 12-Day Tablet Dose Pack (prednisolone tablets USP, 5 mg) Rx onlyprescriptionHuman PrescriptionZylera Pharmaceuticals, Llc2014-03-115235940505
2b8fadaec-9985-4f17-9b2f-b2f6a28cae1c (view SPL)prescriptionHuman PrescriptionLaser Pharmaceuticals, Llc2011-10-241164770505

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