Application 091135

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	SUSPENSION, EXTENDED RELEASE;ORAL	EQ 30MG HYDROBROMIDE/5ML	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
A091135-001	DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL			2012-05-25

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense cough dm	DEXTROMETHORPHAN POLISTIREX	L. Perrigo Company	1b11b25b-2716-45f9-830f-ddf622366e60	2025-11-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	H E B	f8f225cd-a0f2-4991-828f-cc7549778235	2025-11-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 37808-384
Topcare Cough DM	DEXTROMETHORPHAN POLISTIREX	Topco Associates LLC	d1740816-425d-4327-9cff-6ca5ce430d0c	2025-10-31	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 36800-552
Leader Cough DM	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	4c99b5e3-cd79-4c54-ae37-3673c836e668	2025-10-31	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Publix Super Markets Inc	5a71cad4-8816-47f4-840c-27765d377f0a	2025-09-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 56062-384
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	fb6fce1e-2dea-485c-be18-c6764454fe25	2025-09-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 41250-384
cough dm childrens	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	8af9367e-aa0b-4f9e-a7df-737d5411bc3c	2025-06-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 41250-899
cough dm	DEXTROMETHORPHAN POLISTIREX	ATLANTIC BIOLOGICALS CORP.	73aede9d-37dd-4aa5-a906-0e0c94cecff1	2025-05-12	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	3febf0e0-b587-495a-9608-3a2dfbc32791	2025-05-07	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 41250-958
dextromethorphan polistirex extended release	DEXTROMETHORPHAN POLISTIREX	Bryant Ranch Prepack	bd415342-90e1-411b-b6c9-652e9532c611	2025-04-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Robitussin 12 Hour Cough Relief	DEXTROMETHORPHAN POLISTIREX	Haleon US Holdings LLC	5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5	2024-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Childrens Robitussin 12 Hour Cough Relief	DEXTROMETHORPHAN POLISTIREX	Haleon US Holdings LLC	6bcad434-5714-443c-ba83-ed534df9f20a	2024-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
equaline cough dm	DEXTROMETHORPHAN POLISTIREX	United Natural Foods, Inc. dba UNFI	16de32bb-1d02-470b-82b6-9b4366e19817	2023-07-24	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 41163-384
signature care 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Safeway	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	2023-06-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	cb71164f-e4bf-48b9-a8b1-f7271d38a588	2022-06-29	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
signature care childrens 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Safeway	62d71572-d157-484a-8676-7ce6da413ee8	2022-06-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
basic care cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	8127c389-c1e3-4f2e-b306-13587b5b50c4	2021-08-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
basic care childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	dcfb71a1-2a5b-4847-a23d-bbe381badcf6	2021-07-20	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Signature Care Cough Relief	DEXTROMETHORPHAN POLISTIREX	Safeway	f95d0519-e96b-45fe-974c-8fe6b9b8c88c	2021-07-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
basic care childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	5b7c2306-ad87-48b0-99b7-71427907db0c	2021-03-23	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135

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 2 of 3 · 203 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
36800-552	Topcare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-552	Topcare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-899	TopCare Cough DM	Dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-899	TopCare Cough DM	Dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-899	TopCare Cough DM	Dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-958	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-958	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-958	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
37012-384	Cough DM	dextromethorphan polistirex	Shopko Stores Operating Co., LLC	ANDA	Current
37012-384	Cough DM	dextromethorphan polistirex	Shopko Stores Operating Co., LLC	ANDA	Current
37205-697	leader cough dm	dextromethorphan polistirex	Cardinal Health	ANDA	Current
37205-698	leader cough dm	dextromethorphan polistirex	Cardinal Health	ANDA	Current
37808-384	Cough DM	dextromethorphan polistirex	H E B	ANDA	Current
37808-384	Cough DM	dextromethorphan polistirex	H E B	ANDA	Current
37808-384	Cough DM	dextromethorphan polistirex	H E B	ANDA	Current
41163-384	equaline cough dm	dextromethorphan polistirex	Supervalu Inc	ANDA	Current
41163-384	equaline cough dm	dextromethorphan polistirex	Supervalu Inc	ANDA	Current
41163-384	equaline cough dm	dextromethorphan polistirex	Supervalu Inc	ANDA	Current
41163-958	Equaline Cough DM	dextromethorphan polistirex	Supervalu Inc	ANDA	Current
41163-958	Equaline Cough DM	dextromethorphan polistirex	Supervalu Inc	ANDA	Current
41250-384	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-384	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-494	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-494	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-494	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-899	cough dm	Dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41250-958	Cough DM	dextromethorphan polistirex	Meijer Distribution Inc	ANDA	Current
41520-384	CareOne Cough DM	dextromethorphan polistirex	American Sales Company	ANDA	Current
41520-384	CareOne Cough DM	dextromethorphan polistirex	American Sales Company	ANDA	Current
41520-384	CareOne Cough DM	dextromethorphan polistirex	American Sales Company	ANDA	Current
41520-958	CareOne Cough DM	dextromethorphan polistirex	American Sales Company	ANDA	Current
41520-958	CareOne Cough DM	dextromethorphan polistirex	American Sales Company	ANDA	Current
42507-384	cough dm	dextromethorphan polistirex	HyVee Inc	ANDA	Current
42507-958	Cough DM	dextromethorphan polistirex	HyVee Inc	ANDA	Current
45802-433	dextromethorphan polistirex extended release	dextromethorphan polistirex	Perrigo New York Inc	ANDA	Current
45802-433	dextromethorphan polistirex extended release	dextromethorphan polistirex	Perrigo New York Inc	ANDA	Current
45802-433	dextromethorphan polistirex extended release	dextromethorphan polistirex	Perrigo New York Inc	ANDA	Current
45802-433	dextromethorphan polistirex extended release	dextromethorphan polistirex	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
46122-141	Good Neighbor Pharmacy Cough DM ER	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-141	Good Neighbor Pharmacy Cough DM ER	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-141	Good Neighbor Pharmacy Cough DM ER	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-142	Good Neighbor Pharmacy Cough DM ER	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-142	Good Neighbor Pharmacy Cough DM ER	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-293	Good Neighbor Pharmacy Cough	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-293	Good Neighbor Pharmacy Cough	dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-294	Good Neighbor Pharmacy Cough DM ER	Dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
46122-294	Good Neighbor Pharmacy Cough DM ER	Dextromethorphan polistirex	Amerisource Bergen	ANDA	Current
49035-384	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-384	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-384	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-899	equate cough dm	Dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-899	equate cough dm	Dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-899	equate cough dm	Dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-958	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-958	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49035-958	Equate Cough DM	dextromethorphan polistirex	Wal-Mart Stores Inc	ANDA	Current
49348-100	Sunmark cough dm	dextromethorphan polistirex	Strategic Sourcing Services LLC	ANDA	Current
49348-100	Sunmark cough dm	dextromethorphan polistirex	McKesson	ANDA	Current
49348-315	Sunmark cough dm	dextromethorphan polistirex	Strategic Sourcing Services LLC	ANDA	Current
49348-315	Sunmark cough dm	dextromethorphan polistirex	McKesson	ANDA	Current
49738-384	Smart Sense Cough DM	dextromethorphan polistirex	Kmart Corporation	ANDA	Current
49738-384	Smart Sense Cough DM	dextromethorphan polistirex	Kmart Corporation	ANDA	Current
49738-958	Smart Sense Cough DM	dextromethorphan polistirex	Kmart Corporation	ANDA	Current
49738-958	Smart Sense Cough DM	dextromethorphan polistirex	Kmart Corporation	ANDA	Current
49781-138	leader cough dm	dextromethorphan polistirex	Cardinal Health	ANDA	Current
50436-0433	dextromethorphan polistirex extended release	dextromethorphan polistirex	Unit Dose Services	ANDA	Current
55316-384	healthy accents cough relief	dextromethorphan polistirex	DZA Brands LLC	ANDA	Current
55316-384	healthy accents cough relief	dextromethorphan polistirex	DZA Brands LLC	ANDA	Current
55910-384	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
55910-384	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
55910-384	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
55910-958	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
55910-958	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
55910-958	DG Health Cough DM	dextromethorphan polistirex	Dolgencorp, LLC	ANDA	Current
56062-384	Cough DM	dextromethorphan polistirex	Publix Super Markets Inc	ANDA	Current
56062-384	Cough DM	dextromethorphan polistirex	Publix Super Markets Inc	ANDA	Current
56062-384	Cough DM	dextromethorphan polistirex	Publix Super Markets Inc	ANDA	Current
59779-384	Cough DM	dextromethorphan polistirex	CVS Pharmacy	ANDA	Current
59779-384	Cough DM	dextromethorphan polistirex	CVS Pharmacy	ANDA	Current
59779-384	Cough DM	dextromethorphan polistirex	CVS Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48434	ORIG	2017-05-17
9320	ORIG	2012-05-30