Application 040712

Type: ANDA
Sponsor: KVK TECH

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
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE 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
A040712-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31
A040712-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04
A040712-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040712-001	AB
A040712-002	AB
A040712-003	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 · 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	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	AB	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 68071-4424
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 68071-4737
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 43063-874
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 43063-876
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 43063-875
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 10702-002 ndc (product): 10702-004 ndc (product): 10702-003
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 68071-4686
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 50090-4452
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 50090-4608
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 50090-4750
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 50090-4453
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (product): 54348-117
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-8195	Promethazine Hydrochloride	Promethazine Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-051	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-002	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-002	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-003	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-003	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-004	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-004	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	KVK-Tech, Inc.	ANDA	Current
33261-131	Promethazine Hydrochloride	Promethazine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-865	Promethazine Hydrochloride	Promethazine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-874	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-875	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-876	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-876	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-876	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-876	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-592	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	medsource pharmaceuticals	ANDA	Current
50090-4452	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4453	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4453	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4453	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4608	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4750	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4750	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	A-S Medication Solutions	ANDA	Current
50436-4379	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Unit Dose Services	ANDA	Current
53002-4020	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4020	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53808-0546	Promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
54348-117	Promethazine	PROMETHAZINE	PharmPak, Inc.	ANDA	Current
54348-117	Promethazine	PROMETHAZINE	PharmPak, Inc.	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Quality Care Products LLC	ANDA	Current
55700-221	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-690	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-690	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-690	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-149	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
60429-149	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-149	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-149	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-149	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-150	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-151	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-151	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-151	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-151	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-151	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-7670	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7670	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7670	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-0564	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	RedPharm Drug, Inc.	ANDA	Current
67296-0564	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	RedPharm Drug, Inc.	ANDA	Current
67296-0564	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	RedPharm Drug, Inc.	ANDA	Current
68071-4424	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4424	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4686	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4686	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4737	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4737	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29963	ORIG	2006-08-11