Application 202640

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202640-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17
A202640-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17
A202640-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202640-001	AA
A202640-002	AA
A202640-003	AA

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202640-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202640-001	AA	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE	Preferred Pharmaceuticals Inc.	f755f8f3-7645-433c-b502-c1f15b700299	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	dab43efd-bec6-472f-b13a-1c043914dcd1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	1079db3f-d8ad-4c25-aa91-8ac8054ee4f2	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	52ee9258-8311-e6bd-e063-6294a90a567f	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	4727e7a9-eabb-a2a7-e063-6394a90a8754	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	55e262d9-d9dd-43a3-bc74-35e46dd391be	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	949f7347-8c3a-43ce-b975-8d187096f09f	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	NCS HealthCare of KY, LLC dba Vangard Labs	1a33dec1-8d59-48bd-aaef-77d162194d57	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Aurobindo Pharma Limited	beb3c7f2-c0f4-41d9-a903-63a6847e0997	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5485	Meclizine Hydrochloride	Meclizine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5486	Meclizine Hydrochloride	Meclizine	Mylan Pharmaceuticals Inc.	ANDA	Current
43063-662	Meclizine Hydrochloride	Meclizine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-662	Meclizine Hydrochloride	Meclizine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2048	Meclizine Hydrochloride	Meclizine	A-S Medication Solutions	ANDA	Current
51079-423	Meclizine Hydrochloride	Meclizine	Mylan Institutional Inc.	ANDA	Current
51079-511	Meclizine Hydrochloride	Meclizine	Mylan Institutional Inc.	ANDA	Current