Application 074896

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG;15MG	No	No
002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG;25MG	No	Yes
003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG;25MG	No	No
004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG;15MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29
A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29
A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29
A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL		1997-12-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL		1997-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL		1997-12-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL		1997-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL		1997-12-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL		1997-12-29	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	Rising Pharma Holdings, Inc.	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	2023-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074896 application number: ANDA074896

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0081	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0081	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0083	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0083	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0084	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0084	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0086	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0086	Captopril and Hydrochlorothiazide	captopril and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current