Application 083312

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	No	Yes
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083312-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
A083312-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, 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
A083312-001	AP
A083312-002	AP

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083312-001	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083312-002	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A083312-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083312-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083312-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083312-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083312-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083312-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083312-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083312-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083312-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083312-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083312-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083312-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083312-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083312-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083312-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083312-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083312-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083312-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083312-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083312-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083312-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083312-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083312-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083312-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083312-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083312-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083312-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083312-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083312-002	AP	1	`782e0a99824c…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	7fa840ad-10e7-4faf-9325-451648604161	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0404-9940
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	7ce351d8-47be-4937-aad2-153208c93b53	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 55154-2861
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	38673af1-112e-9ddd-e063-6294a90af465	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	d7675718-0a57-41ff-a771-79afc12150aa	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0404-9941
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	c525cb2c-9a01-4a9b-ad2c-08630719953d	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0404-9942
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	13d9e59d-eadb-41d5-9f47-9c11a6efb31c	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-1495 ndc (product): 0641-1496
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	d545105f-27dc-4820-b0b1-fcf17e0be0f0	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-0948 ndc (product): 0641-0949
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	6f7e47cc-f823-4336-8107-f980e3049617	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-6082 ndc (product): 0641-6083
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4bf3912c-8339-401e-9711-dad6acf15f11	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-0928 ndc (product): 0641-0929
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	481866da-a712-48a5-853f-8e84aacaab6d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-6085 ndc (product): 0641-6084
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-6208
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	365138a6-28d8-4881-a3e9-02c80aaf83e8	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 0641-0955 ndc (product): 0641-0956
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 51662-1248
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	7447e8c6-c198-cd2d-e053-2a91aa0a3895	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 51662-1247
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	677b5fc5-94be-638b-e053-2991aa0a7f97	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 71872-7077
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dc8b50de-e4f6-607f-e053-2995a90a2902	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 71872-7285
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	c930985b-bba3-4f3a-a1ae-1d808670efde	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083312 application number: ANDA083312 ndc (product): 50090-0879

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 72 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9940	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	ANDA	Current
0404-9940	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	ANDA	Current
0404-9941	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9941	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9941	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9942	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9942	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9942	Promethazine Hydrochloride	Promethazine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0641-0928	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0928	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0929	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0929	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0948	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0948	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0949	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0949	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0955	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0955	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0956	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0956	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1495	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1495	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-1496	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1496	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6082	PHENERGAN	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6082	PHENERGAN	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6083	PHENERGAN	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6083	PHENERGAN	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6084	PHENERGAN	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6084	PHENERGAN	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6085	PHENERGAN	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6085	PHENERGAN	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6099	Promethazine Hydrochloride	Promethazine Hydrochloride	West-ward Pharmaceutical Corp.	ANDA	Current
0641-6208	Promethazine Hydrochloride	Promethazine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6208	Promethazine Hydrochloride	Promethazine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
50090-0879	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0879	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
52584-078	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-078	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-078	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-495	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-495	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-495	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-495	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-496	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-496	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-496	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-496	Promethazine Hydrochloride	Promethazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
55154-2860	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
55154-2860	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
55154-2861	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
55154-2861	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-2861	Promethazine Hydrochloride	Promethazine Hydrochloride	Cardinal Health	ANDA	Current
68258-3028	Promethazine Hydrochloride	Promethazine Hydrochloride	Dispensing Solutions Inc.	ANDA	Current
70518-2656	PHENERGAN	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2656	PHENERGAN	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2896	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2896	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3340	Promethazine Hydrochloride	Promethazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71872-7077	Promethazine Hydrochloride	Promethazine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7077	Promethazine Hydrochloride	Promethazine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7285	Promethazine Hydrochloride	Promethazine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current