Hydrochlorothiazide / Propranolol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-06-09)
Oldest Current Product
1987-03-04
License(s)
ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:PROPRANOLOL
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: PROPRANOLOL HYDROCHLORIDE
SPL Active
ORAL\TABLET\HYDROCHLOROTHIAZIDE: PROPRANOLOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\HYDROCHLOROTHIAZIDE: PROPRANOLOL

product(s) by strength(s)

hydrochlorothiazide 25 mg / propranolol hydrochloride 40 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780731ANDAMylan Pharmaceuticals Inc.1987-03-04HYDROCHLOROTHIAZIDE, PROPRANOLOL HYDROCHLORIDEORALTABLETANDA07094790656b7e-c3b6-46f9-9428-421b7d61d0cc

hydrochlorothiazide 25 mg / propranolol hydrochloride 80 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780347ANDAMylan Pharmaceuticals Inc.1987-04-01HYDROCHLOROTHIAZIDE, PROPRANOLOL HYDROCHLORIDEORALTABLETANDA07094790656b7e-c3b6-46f9-9428-421b7d61d0cc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070301PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-04-18ANDA070301_001
2ANDA070305PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-04-18ANDA070305_001
3ANDA070704PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueANI PHARMACEUTICALS INC1986-10-01ANDA070704_001
4ANDA070705PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueANI PHARMACEUTICALS INC1986-10-01ANDA070705_001
5ANDA070851PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueACTAVIS ELIZABETH LLC1986-05-15ANDA070851_001
6ANDA070852PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueACTAVIS ELIZABETH LLC1986-05-15ANDA070852_001
7ANDA070947PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC1987-03-04ANDA070947_001, ANDA070947_002
8ANDA071060PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1987-08-26ANDA071060_001
9ANDA071061PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1987-08-26ANDA071061_001
10ANDA071126PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1987-03-02ANDA071126_001
11ANDA071127PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1987-03-02ANDA071127_001
12ANDA071498PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1991-12-18ANDA071498_001
13ANDA071501PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1991-12-18ANDA071501_001
14ANDA071552PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-12-01ANDA071552_001
15ANDA071553PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-12-01ANDA071553_001
16ANDA071771PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1988-01-26ANDA071771_001
17ANDA071772PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1988-01-26ANDA071772_001
18ANDA072042PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEANI PHARMACEUTICALS INC1988-03-14ANDA072042_001
19ANDA072043PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEANI PHARMACEUTICALS INC1988-03-14ANDA072043_001
20NDA018031INDERIDE-40/25TrueWYETH PHARMACEUTICALS INCNDA018031_001, NDA018031_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070301_001discontinuedPROPRANOLOL HYDROCHLORIDE (40MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1986-04-18PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
2ANDA070305_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (80MG)ORALTABLETFalse1986-04-18PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
3ANDA070704_001discontinuedPROPRANOLOL HYDROCHLORIDE (40MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1986-10-01PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
4ANDA070705_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (80MG)ORALTABLETFalse1986-10-01PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
5ANDA070851_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1986-05-15PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
6ANDA070852_001discontinuedPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1986-05-15PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
7ANDA070947_001RXHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (80MG)ORALTABLETTrueAB1987-04-01PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
8ANDA070947_002RXHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETTrueAB1987-03-04PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
9ANDA071060_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1987-08-26PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
10ANDA071061_001discontinuedPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1987-08-26PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
11ANDA071126_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1987-03-02PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
12ANDA071127_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (80MG)ORALTABLETFalse1987-03-02PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
13ANDA071498_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1991-12-18PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
14ANDA071501_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (80MG)ORALTABLETFalse1991-12-18PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
15ANDA071552_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1988-12-01PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
16ANDA071553_001discontinuedPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1988-12-01PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
17ANDA071771_001discontinuedHYDROCHLOROTHIAZIDE (25MG), PROPRANOLOL HYDROCHLORIDE (40MG)ORALTABLETFalse1988-01-26PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
18ANDA071772_001discontinuedPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1988-01-26PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
19ANDA072042_001RXPROPRANOLOL HYDROCHLORIDE (40MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB1988-03-14PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
20ANDA072043_001RXPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseAB1988-03-14PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
21NDA018031_001discontinuedPROPRANOLOL HYDROCHLORIDE (40MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseINDERIDE-40/25
22NDA018031_002discontinuedPROPRANOLOL HYDROCHLORIDE (80MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalseINDERIDE-40/25

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
190656b7e-c3b6-46f9-9428-421b7d61d0cc (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-06-094003780347, 003780731

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