Nifedipine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2011-10-17
License(s)
ANDA
RxNORM
ORAL TABLET\NIFEDIPINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NIFEDIPINE
SPL Active
ORAL\TABLET\NIFEDIPINE
SPL Moiety
ORAL\TABLET\NIFEDIPINE

product(s) by strength(s)

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490588ANDARemedyrepack Inc.2011-10-17NIFEDIPINEORALTABLET621750260ANDA0771276139bd81-c3f3-41dd-b69a-6d98c756a3cf

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA075108NIFEDIPINETrueMYLAN PHARMACEUTICALS INC1999-12-17ANDA075108_001Nifedipine Extended Release Oral Tablet
2ANDA075128AFEDITAB CRWATSON LABORATORIES INC2000-03-10ANDA075128_001Nifedipine Extended Release Oral Tablet
3ANDA075269NIFEDIPINEVALEANT INTERNATIONAL BARBADOS SRL2000-12-04ANDA075269_001, ANDA075269_002Nifedipine Extended Release Oral Tablet
4ANDA075289NIFEDIPINEVALEANT PHARMACEUTICALS NORTH AMERICA LLC2000-09-27ANDA075289_001, ANDA075289_002Nifedipine Extended Release Oral Tablet
5ANDA075414NIFEDIPINETrueMARTEC USA LLC2004-03-23ANDA075414_003Nifedipine Extended Release Oral Tablet
6ANDA075659AFEDITAB CRWATSON LABORATORIES INC2001-10-26ANDA075659_001Nifedipine Extended Release Oral Tablet
7ANDA076070NIFEDIPINEVALEANT INTERNATIONAL BARBADOS SRL2002-08-16ANDA076070_001Nifedipine Extended Release Oral Tablet
8ANDA077127NIFEDIPINEOSMOTICA PHARMACEUTICAL CORP2005-11-21ANDA077127_001, ANDA077127_002Nifedipine Extended Release Oral Tablet
9ANDA077410NIFEDIPINEOSMOTICA PHARMACEUTICAL CORP2007-10-03ANDA077410_001Nifedipine Extended Release Oral Tablet
10ANDA077899NIFEDIPINEPAR PHARMACEUTICAL INC2006-12-13ANDA077899_001, ANDA077899_002, ANDA077899_003Nifedipine Extended Release Oral Tablet
11ANDA090602NIFEDIPINEMATRIX LABORATORIES LTD2010-09-13ANDA090602_001, ANDA090602_002, ANDA090602_003Nifedipine Extended Release Oral Tablet
12ANDA090649NIFEDIPINEMYLAN PHARMACEUTICALS INC2010-06-21ANDA090649_001, ANDA090649_002, ANDA090649_003Nifedipine Extended Release Oral Tablet
13ANDA201071NIFEDIPINEMYLAN PHARMACEUTICALS INC2010-12-03ANDA201071_001, ANDA201071_002, ANDA201071_003Nifedipine Extended Release Oral Tablet
14ANDA203126NIFEDIPINETWI PHARMACEUTICALS INC2014-04-03ANDA203126_001, ANDA203126_002, ANDA203126_003Nifedipine Extended Release Oral Tablet
15NDA019684PROCARDIA XLPFIZER LABORATORIES DIV PFIZER INC1989-09-06NDA019684_001, NDA019684_002, NDA019684_003Nifedipine Extended Release Oral Tablet
16NDA020198ADALAT CCBAYER HEALTHCARE PHARMACEUTICALS INC1993-04-21NDA020198_001, NDA020198_002, NDA020198_003Nifedipine Extended Release Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075108_001discontinuedNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalse1999-12-17NIFEDIPINE
2ANDA075128_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB12000-03-10AFEDITAB CR
3ANDA075269_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB12000-12-04NIFEDIPINE
4ANDA075269_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB12000-12-04NIFEDIPINE
5ANDA075289_001RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB22000-09-27NIFEDIPINE
6ANDA075289_002RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB22001-02-06NIFEDIPINE
7ANDA075414_003discontinuedNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalse2004-03-23NIFEDIPINE
8ANDA075659_001RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB12001-10-26AFEDITAB CR
9ANDA076070_001RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB12002-08-16NIFEDIPINE
10ANDA077127_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB22005-11-21NIFEDIPINE
11ANDA077127_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB22005-11-21NIFEDIPINE
12ANDA077410_001RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB22007-10-03NIFEDIPINE
13ANDA077899_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB12006-12-13NIFEDIPINE
14ANDA077899_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB12006-12-13NIFEDIPINE
15ANDA077899_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB12012-05-25NIFEDIPINE
16ANDA090602_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-09-13NIFEDIPINE
17ANDA090602_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-09-13NIFEDIPINE
18ANDA090602_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-09-13NIFEDIPINE
19ANDA090649_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-06-21NIFEDIPINE
20ANDA090649_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-06-21NIFEDIPINE
21ANDA090649_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB22010-06-21NIFEDIPINE
22ANDA201071_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB12010-12-03NIFEDIPINE
23ANDA201071_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB12010-12-03NIFEDIPINE
24ANDA201071_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB12010-12-03NIFEDIPINE
25ANDA203126_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB22014-04-03NIFEDIPINE
26ANDA203126_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB22014-04-03NIFEDIPINE
27ANDA203126_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASEFalseAB22014-04-03NIFEDIPINE
28NDA019684_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB21989-09-06PROCARDIA XL
29NDA019684_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASEFalseAB21989-09-06PROCARDIA XL
30NDA019684_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASETrueAB21989-09-06PROCARDIA XL
31NDA020198_001RXNIFEDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalseAB11993-04-21ADALAT CC
32NDA020198_002RXNIFEDIPINE (60MG)ORALTABLET, EXTENDED RELEASETrueAB11993-04-21ADALAT CC
33NDA020198_003RXNIFEDIPINE (90MG)ORALTABLET, EXTENDED RELEASETrueAB11993-04-21ADALAT CC

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16139bd81-c3f3-41dd-b69a-6d98c756a3cf (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-172493490588

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