Application 205391

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;20MG	No	No
002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;40MG	No	No
003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	25MG;40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24
A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24
A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205391-001	AB
A205391-002	AB
A205391-003	AB

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205391-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205391-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205391-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205391-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205391-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205391-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205391-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205391-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205391-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205391-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205391-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205391-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205391-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205391-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205391-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205391-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205391-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205391-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205391-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205391-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205391-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205391-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205391-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205391-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205391-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205391-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205391-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205391-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205391-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205391-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205391-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205391-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205391-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205391-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205391-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205391-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205391-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205391-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205391-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205391-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205391-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205391-002	AB	1	`3f01610625f2…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	0360db3a-17cf-4d24-97ba-e0a6fcc94351	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391 ndc (product): 71335-0845
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	744c1785-42b2-46a5-b0f4-2887a9ec2051	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391 ndc (product): 65862-780 ndc (product): 65862-781 ndc (product): 65862-779
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	fe49d96e-5874-4b11-9323-b4a92e9c25dc	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391 ndc (product): 50090-3561
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b78ad43f-f132-4f03-8c85-2cf9b3ab555b	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391 ndc (product): 50090-3701
Olmesartan Medoxomil and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ad1b2af1-3713-4776-bf48-d776073d9781	2024-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205391 application number: ANDA205391 ndc (product): 50090-4377

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3561	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-3561	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-3561	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-3701	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-3701	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-4377	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-4377	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
61919-516	OLMESARTAN MEDOXOMIL/HCTZ	OLMESARTAN MEDOXOMIL/HCTZ	DirectRX	ANDA	Current
63629-7570	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7570	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
65862-779	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-779	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-779	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-780	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-780	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-780	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-781	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-781	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-781	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
68071-4521	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1466	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1466	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1466	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1466	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2181	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2181	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2213	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2213	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
71335-0845	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0845	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0845	Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan Medoxomil and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48132	ORIG	2017-04-25