Minocycline Oral Tablet

Brand(s)
Dynacin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2014-12-18)
Oldest Current Product
2003-04-16
License(s)
ANDA
RxNORM
ORAL TABLET\MINOCYCLINE
FDAOB
ORAL\TABLET\MINOCYCLINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\MINOCYCLINE HYDROCHLORIDE
ORAL\TABLET\MINOCYCLINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\MINOCYCLINE
ORAL\TABLET\MINOCYCLINE

product(s) by strength(s)

minocycline 100 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840098DynacinANDAPar Pharmaceutical Companies, Inc.2011-06-20MINOCYCLINE HYDROCHLORIDEORALTABLETANDA065131f174edbd-3ac0-4e27-a116-3b74804721bb
2498840513ANDAPar Pharmaceutical Companies, Inc.2003-04-16MINOCYCLINE HYDROCHLORIDEORALTABLETANDA06513137baf13f-cc65-44a1-93d9-e5213875af1a
3551110639ANDADr. Reddy'S Laboratories Ltd2008-01-23MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065436aec056cd-4f1f-4971-2bea-0b05ee028889
4633040699ANDARnabaxy Pharmaceuticals Inc.2004-06-29MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065156b4db7cdc-bcad-4825-9840-6c36246c6d31

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910591ANDAAvkare, Inc.2015-05-08MINOCYCLINE HYDROCHLORIDEORALTABLET498840513ANDA065131ad8678de-ee78-d061-ea5f-d2a6b949b0e5

minocycline 50 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840096DynacinANDAPar Pharmaceutical Companies, Inc.2011-06-20MINOCYCLINE HYDROCHLORIDEORALTABLETANDA065131f174edbd-3ac0-4e27-a116-3b74804721bb
2498840511ANDAPar Pharmaceutical Companies, Inc.2003-04-16MINOCYCLINE HYDROCHLORIDEORALTABLETANDA06513137baf13f-cc65-44a1-93d9-e5213875af1a
3551110637ANDADr. Reddy'S Laboratories Ltd2008-01-23MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065436aec056cd-4f1f-4971-2bea-0b05ee028889
4633040697ANDARnabaxy Pharmaceuticals Inc.2004-06-29MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065156b4db7cdc-bcad-4825-9840-6c36246c6d31

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910589ANDAAvkare, Inc.2015-05-08MINOCYCLINE HYDROCHLORIDEORALTABLET498840511ANDA065131ad8678de-ee78-d061-ea5f-d2a6b949b0e5

minocycline 75 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840097DynacinANDAPar Pharmaceutical Companies, Inc.2011-06-20MINOCYCLINE HYDROCHLORIDEORALTABLETANDA065131f174edbd-3ac0-4e27-a116-3b74804721bb
2498840512ANDAPar Pharmaceutical Companies, Inc.2003-04-16MINOCYCLINE HYDROCHLORIDEORALTABLETANDA06513137baf13f-cc65-44a1-93d9-e5213875af1a
3551110638ANDADr. Reddy'S Laboratories Ltd2008-01-23MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065436aec056cd-4f1f-4971-2bea-0b05ee028889
4633040698ANDARnabaxy Pharmaceuticals Inc.2004-06-29MINOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065156b4db7cdc-bcad-4825-9840-6c36246c6d31

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065131MINOCYCLINE HYDROCHLORIDEPAR PHARMACEUTICAL INC2003-04-16ANDA065131_001, ANDA065131_002, ANDA065131_003
2ANDA065156MINOCYCLINE HYDROCHLORIDETORRENT PHARMA INC2004-01-06ANDA065156_001, ANDA065156_002, ANDA065156_003
3ANDA065436MINOCYCLINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2007-12-26ANDA065436_001, ANDA065436_002, ANDA065436_003
4NDA050451MINOCYCLINE HYDROCHLORIDETrueTRIAX PHARMACEUTICALS LLC1982-08-10NDA050451_002, NDA050451_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065131_001RXMINOCYCLINE HYDROCHLORIDE (EQ 50MG BASE)ORALTABLETFalseAB2003-04-16MINOCYCLINE HYDROCHLORIDE
2ANDA065131_002RXMINOCYCLINE HYDROCHLORIDE (EQ 75MG BASE)ORALTABLETFalseAB2003-04-16MINOCYCLINE HYDROCHLORIDE
3ANDA065131_003RXMINOCYCLINE HYDROCHLORIDE (EQ 100MG BASE)ORALTABLETTrueAB2003-04-16MINOCYCLINE HYDROCHLORIDE
4ANDA065156_001RXMINOCYCLINE HYDROCHLORIDE (EQ 50MG BASE)ORALTABLETFalseAB2004-01-06MINOCYCLINE HYDROCHLORIDE
5ANDA065156_002RXMINOCYCLINE HYDROCHLORIDE (EQ 75MG BASE)ORALTABLETFalseAB2004-01-06MINOCYCLINE HYDROCHLORIDE
6ANDA065156_003RXMINOCYCLINE HYDROCHLORIDE (EQ 100MG BASE)ORALTABLETFalseAB2004-01-06MINOCYCLINE HYDROCHLORIDE
7ANDA065436_001RXMINOCYCLINE HYDROCHLORIDE (EQ 50MG BASE)ORALTABLETFalseAB2007-12-26MINOCYCLINE HYDROCHLORIDE
8ANDA065436_002RXMINOCYCLINE HYDROCHLORIDE (EQ 75MG BASE)ORALTABLETFalseAB2007-12-26MINOCYCLINE HYDROCHLORIDE
9ANDA065436_003RXMINOCYCLINE HYDROCHLORIDE (EQ 100MG BASE)ORALTABLETFalseAB2007-12-26MINOCYCLINE HYDROCHLORIDE
10NDA050451_002discontinuedMINOCYCLINE HYDROCHLORIDE (EQ 100MG BASE)ORALTABLETFalse1982-08-10MINOCYCLINE HYDROCHLORIDE
11NDA050451_003discontinuedMINOCYCLINE HYDROCHLORIDE (EQ 50MG BASE)ORALTABLETFalse1982-08-10MINOCYCLINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
137baf13f-cc65-44a1-93d9-e5213875af1a (view SPL)Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2012-09-053498840511, 498840512, 498840513
2ad8678de-ee78-d061-ea5f-d2a6b949b0e5 (view SPL)Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionAvkare, Inc.2015-05-081422910589, 422910591
3aec056cd-4f1f-4971-2bea-0b05ee028889 (view SPL)prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2014-11-137551110637, 551110638, 551110639
4b4db7cdc-bcad-4825-9840-6c36246c6d31 (view SPL)prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2011-09-234633040697, 633040698, 633040699
5f174edbd-3ac0-4e27-a116-3b74804721bb (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-12-184498840096, 498840097, 498840098

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