Hydrochlorothiazide / Methyldopa Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2010-01-18)
Oldest Current Product
1986-01-23
License(s)
ANDA
RxNORM
ORAL TABLET\HYDROCHLOROTHIAZIDE:METHYLDOPA
FDAOB
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METHYLDOPA
SPL Active
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METHYLDOPA
SPL Moiety
ORAL\TABLET\HYDROCHLOROTHIAZIDE: METHYLDOPA ANHYDROUS

product(s) by strength(s)

hydrochlorothiazide 15 mg / methyldopa 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780507ANDAMylan Pharmaceuticals Inc.1986-01-23HYDROCHLOROTHIAZIDE, METHYLDOPAORALTABLETANDA0702655bf74178-66b8-44d4-a87d-1fd760b94ad3

hydrochlorothiazide 25 mg / methyldopa 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780711ANDAMylan Pharmaceuticals Inc.1986-01-23HYDROCHLOROTHIAZIDE, METHYLDOPAORALTABLETANDA0702655bf74178-66b8-44d4-a87d-1fd760b94ad3

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070182METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1986-01-15ANDA070182_001
2ANDA070183METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1986-01-15ANDA070183_001
3ANDA070265METHYLDOPA AND HYDROCHLOROTHIAZIDEMYLAN PHARMACEUTICALS INC1986-01-23ANDA070265_001, ANDA070265_002
4ANDA070365METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-03-19ANDA070365_001
5ANDA070366METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-04-16ANDA070366_001
6ANDA070367METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-03-19ANDA070367_001
7ANDA070368METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1986-04-16ANDA070368_001
8ANDA070543METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1986-01-15ANDA070543_001
9ANDA070544METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1986-01-15ANDA070544_001
10ANDA070612METHYLDOPA AND HYDROCHLOROTHIAZIDETruePAR PHARMACEUTICAL INC1987-02-02ANDA070612_001
11ANDA070613METHYLDOPA AND HYDROCHLOROTHIAZIDETruePAR PHARMACEUTICAL INC1987-02-02ANDA070613_001
12ANDA070614METHYLDOPA AND HYDROCHLOROTHIAZIDETruePAR PHARMACEUTICAL INC1987-02-02ANDA070614_001
13ANDA070616METHYLDOPA AND HYDROCHLOROTHIAZIDETruePAR PHARMACEUTICAL INC1987-02-02ANDA070616_001
14ANDA070688METHYLDOPA AND HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1986-04-24ANDA070688_001
15ANDA070689METHYLDOPA AND HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1986-04-24ANDA070689_001
16ANDA070829METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1987-03-09ANDA070829_001
17ANDA070830METHYLDOPA AND HYDROCHLOROTHIAZIDETrueSANDOZ INC1987-03-09ANDA070830_001
18ANDA070853METHYLDOPA AND HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1986-10-08ANDA070853_001
19ANDA070854METHYLDOPA AND HYDROCHLOROTHIAZIDETruePUREPAC PHARMACEUTICAL CO1986-10-08ANDA070854_001
20ANDA070958METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1989-02-06ANDA070958_001
21ANDA070959METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1989-01-19ANDA070959_001
22ANDA070960METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1989-02-06ANDA070960_001
23ANDA071069METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1989-01-19ANDA071069_001
24ANDA071458METHYLDOPA AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-03-08ANDA071458_001
25ANDA071459METHYLDOPA AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-03-08ANDA071459_001
26ANDA071460METHYLDOPA AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-03-08ANDA071460_001
27ANDA071461METHYLDOPA AND HYDROCHLOROTHIAZIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-03-08ANDA071461_001
28ANDA071819METHYLDOPA AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC1988-04-08ANDA071819_001
29ANDA071820METHYLDOPA AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC1988-04-08ANDA071820_001
30ANDA071821METHYLDOPA AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC1988-04-08ANDA071821_001
31ANDA071822METHYLDOPA AND HYDROCHLOROTHIAZIDETrueTEVA PHARMACEUTICALS USA INC1988-04-08ANDA071822_001
32ANDA071897METHYLDOPA AND HYDROCHLOROTHIAZIDETruePARKE DAVIS DIV WARNER LAMBERT CO1987-11-23ANDA071897_001
33ANDA071898METHYLDOPA AND HYDROCHLOROTHIAZIDETruePARKE DAVIS DIV WARNER LAMBERT CO1987-11-23ANDA071898_001
34ANDA071899METHYLDOPA AND HYDROCHLOROTHIAZIDETruePARKE DAVIS DIV WARNER LAMBERT CO1987-11-23ANDA071899_001
35ANDA071900METHYLDOPA AND HYDROCHLOROTHIAZIDETruePARKE DAVIS DIV WARNER LAMBERT CO1987-11-23ANDA071900_001
36ANDA071920METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1988-08-29ANDA071920_001
37ANDA071921METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1988-08-29ANDA071921_001
38ANDA071922METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1988-08-29ANDA071922_001
39ANDA071923METHYLDOPA AND HYDROCHLOROTHIAZIDETrueWATSON LABORATORIES INC1988-08-29ANDA071923_001
40ANDA072507METHYLDOPA AND HYDROCHLOROTHIAZIDETrueDAVA PHARMACEUTICALS INC1989-06-02ANDA072507_001
41ANDA072508METHYLDOPA AND HYDROCHLOROTHIAZIDETrueDAVA PHARMACEUTICALS INC1989-06-02ANDA072508_001
42ANDA072509METHYLDOPA AND HYDROCHLOROTHIAZIDETrueDAVA PHARMACEUTICALS INC1989-06-02ANDA072509_001
43ANDA072510METHYLDOPA AND HYDROCHLOROTHIAZIDETrueDAVA PHARMACEUTICALS INC1989-06-02ANDA072510_001
44NDA013402ALDORIL 15TrueMERCK AND CO INCNDA013402_001, NDA013402_002, NDA013402_003, NDA013402_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070182_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1986-01-15METHYLDOPA AND HYDROCHLOROTHIAZIDE
2ANDA070183_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1986-01-15METHYLDOPA AND HYDROCHLOROTHIAZIDE
3ANDA070265_001RXMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETTrue1986-01-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
4ANDA070265_002RXHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1986-01-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
5ANDA070365_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1986-03-19METHYLDOPA AND HYDROCHLOROTHIAZIDE
6ANDA070366_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1986-04-16METHYLDOPA AND HYDROCHLOROTHIAZIDE
7ANDA070367_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1986-03-19METHYLDOPA AND HYDROCHLOROTHIAZIDE
8ANDA070368_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalse1986-04-16METHYLDOPA AND HYDROCHLOROTHIAZIDE
9ANDA070543_001discontinuedHYDROCHLOROTHIAZIDE (30MG), METHYLDOPA (500MG)ORALTABLETFalse1986-01-15METHYLDOPA AND HYDROCHLOROTHIAZIDE
10ANDA070544_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalse1986-01-15METHYLDOPA AND HYDROCHLOROTHIAZIDE
11ANDA070612_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1987-02-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
12ANDA070613_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1987-02-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
13ANDA070614_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1987-02-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
14ANDA070616_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1987-02-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
15ANDA070688_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1986-04-24METHYLDOPA AND HYDROCHLOROTHIAZIDE
16ANDA070689_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1986-04-24METHYLDOPA AND HYDROCHLOROTHIAZIDE
17ANDA070829_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1987-03-09METHYLDOPA AND HYDROCHLOROTHIAZIDE
18ANDA070830_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1987-03-09METHYLDOPA AND HYDROCHLOROTHIAZIDE
19ANDA070853_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1986-10-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
20ANDA070854_001discontinuedHYDROCHLOROTHIAZIDE (30MG), METHYLDOPA (500MG)ORALTABLETFalse1986-10-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
21ANDA070958_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1989-02-06METHYLDOPA AND HYDROCHLOROTHIAZIDE
22ANDA070959_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1989-01-19METHYLDOPA AND HYDROCHLOROTHIAZIDE
23ANDA070960_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1989-02-06METHYLDOPA AND HYDROCHLOROTHIAZIDE
24ANDA071069_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1989-01-19METHYLDOPA AND HYDROCHLOROTHIAZIDE
25ANDA071458_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1988-03-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
26ANDA071459_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1988-03-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
27ANDA071460_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1988-03-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
28ANDA071461_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1988-03-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
29ANDA071819_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalse1988-04-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
30ANDA071820_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1988-04-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
31ANDA071821_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1988-04-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
32ANDA071822_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1988-04-08METHYLDOPA AND HYDROCHLOROTHIAZIDE
33ANDA071897_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1987-11-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
34ANDA071898_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1987-11-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
35ANDA071899_001discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalse1987-11-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
36ANDA071900_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1987-11-23METHYLDOPA AND HYDROCHLOROTHIAZIDE
37ANDA071920_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1988-08-29METHYLDOPA AND HYDROCHLOROTHIAZIDE
38ANDA071921_001discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalse1988-08-29METHYLDOPA AND HYDROCHLOROTHIAZIDE
39ANDA071922_001discontinuedHYDROCHLOROTHIAZIDE (30MG), METHYLDOPA (500MG)ORALTABLETFalse1988-08-29METHYLDOPA AND HYDROCHLOROTHIAZIDE
40ANDA071923_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1988-08-29METHYLDOPA AND HYDROCHLOROTHIAZIDE
41ANDA072507_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (15MG)ORALTABLETFalse1989-06-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
42ANDA072508_001discontinuedMETHYLDOPA (250MG), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse1989-06-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
43ANDA072509_001discontinuedHYDROCHLOROTHIAZIDE (30MG), METHYLDOPA (500MG)ORALTABLETFalse1989-06-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
44ANDA072510_001discontinuedHYDROCHLOROTHIAZIDE (50MG), METHYLDOPA (500MG)ORALTABLETFalse1989-06-02METHYLDOPA AND HYDROCHLOROTHIAZIDE
45NDA013402_001discontinuedHYDROCHLOROTHIAZIDE (15MG), METHYLDOPA (250MG)ORALTABLETFalseALDORIL 15
46NDA013402_002discontinuedHYDROCHLOROTHIAZIDE (25MG), METHYLDOPA (250MG)ORALTABLETFalseALDORIL 15
47NDA013402_003discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (30MG)ORALTABLETFalseALDORIL 15
48NDA013402_004discontinuedMETHYLDOPA (500MG), HYDROCHLOROTHIAZIDE (50MG)ORALTABLETFalseALDORIL 15

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15bf74178-66b8-44d4-a87d-1fd760b94ad3 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-01-186003780507, 003780711

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