Application 084176

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	Yes
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	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	RLD / RS	Approval date
A084176-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A084176-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22
A084176-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A084176-001	AB
A084176-003	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL			2009-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-003	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-001	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084176-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084176-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084176-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084176-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084176-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084176-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084176-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084176-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084176-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084176-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084176-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084176-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084176-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084176-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084176-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084176-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084176-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084176-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084176-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084176-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084176-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084176-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084176-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084176-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084176-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084176-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084176-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084176-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084176-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084176-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084176-003	AB	1	`74a2ff9319b5…`

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Redpharm Drug	5a797d11-19b0-fd33-e063-6394a90a4d58	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	974208c8-4aad-4fb9-991b-cf3085034272	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	5991de26-891a-153a-e063-6294a90a4633	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	55f618d1-4466-3200-e063-6394a90a89a8	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Atlantic Biologicals Corp.	4f99bbd5-02f7-2fed-e063-6394a90a6355	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	bf951b5b-6e38-44a9-895e-0d60c6b9d343	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	81fd29a9-c090-49ba-8b48-bd3656ca0c92	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1830	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1830	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1830	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1832	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1832	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1832	Promethazine Hydrochloride	Promethazine Hydrochloride	Sandoz Inc	ANDA	Current
0904-6461	Promethazine Hydrochloride	Promethazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6461	Promethazine Hydrochloride	Promethazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
50090-2906	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3077	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
55154-8080	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
55154-8080	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
55154-8080	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
63739-213	Promethazine Hydrochloride	Promethazine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-213	Promethazine Hydrochloride	Promethazine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current