Application 083426

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083426-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083426-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A083426-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A083426-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083426-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083426-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083426-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083426-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083426-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083426-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083426-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083426-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083426-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083426-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083426-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083426-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083426-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083426-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083426-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083426-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083426-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083426-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083426-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083426-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083426-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083426-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083426-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083426-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083426-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083426-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083426-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083426-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083426-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083426-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083426-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083426-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083426-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083426-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083426-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083426-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083426-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083426-001	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	f6ca1097-1c75-c682-e053-6294a90a2bd6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	74834e1b-0d90-0542-e053-2991aa0aa1ef	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426 ndc (product): 68071-4544
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	08bf9fbf-cc21-41a0-9e81-ec498aa64170	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426 ndc (product): 63187-829
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Actavis Pharma, Inc.	a32255f0-0077-489e-bdc6-869aca8cd434	2016-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426 ndc (product): 0591-5307

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
10544-618	Promethazine Hydrochloride	Promethazine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
21695-453	Promethazine hydrochloride	Promethazine hydrochloride	Rebel Distributors Corp	ANDA	Current
49999-090	Promethazine Hydrochloride	Promethazine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1902	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1904	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4603	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
58118-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	Clinical Solutions Wholesale	ANDA	Current
58118-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	Clinical Solutions Wholesale	ANDA	Current
58118-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	Clinical Solutions Wholesale	ANDA	Current
61919-191	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-191	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-191	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-191	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-191	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-829	Promethazine Hydrochloride	Promethazine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-829	Promethazine Hydrochloride	Promethazine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-1742	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1742	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1742	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6327	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6327	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
64725-5307	Promethazine Hydrochloride	Promethazine Hydrochloride	TYA Pharmaceuticals	ANDA	Current
67296-0086	Promethazine Hydrochloride	Promethazine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0086	Promethazine Hydrochloride	Promethazine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0086	Promethazine Hydrochloride	Promethazine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-4514	Promethazine Hydrochloride	Promethazine Hydrochloride	NuCare Pharmaceuticals,In	ANDA	Current
68071-4514	Promethazine Hydrochloride	Promethazine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4514	Promethazine Hydrochloride	Promethazine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4544	Promethazine Hydrochloride	Promethazine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4544	Promethazine Hydrochloride	Promethazine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7287	Promethazine Hydrochloride	Promethazine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2481	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2481	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2481	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2481	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-139	Promethazine Hydrochloride	Promethazine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-139	Promethazine Hydrochloride	Promethazine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current