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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`f41ea6bd6efb…`

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 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
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
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
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 ndc (product): 17856-6312
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
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
dextromethorphan polistirex extended release	DEXTROMETHORPHAN POLISTIREX	Padagis Israel Pharmaceuticals Ltd	7a6b68eb-8fe0-447d-aed7-28432c45b58c	2025-02-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	a9765a9b-3ae3-45bc-ab59-06ec5249e2c9	2025-02-11	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 ndc (product): 0031-8754 ndc (product): 0031-8755 ndc (product): 0031-8753 ndc (product): 0031-8655
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 ndc (product): 0031-8725 ndc (product): 0031-8726
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
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 ndc (product): 21130-012
Cough DM	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	be67fb34-6ecb-4b45-9a67-3f78f4af8e36	2023-06-06	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 0363-0494
Cough DM	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	c628923a-6771-4aba-9e2d-4795c9effb33	2023-04-04	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 0363-0384
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 ndc (product): 21130-890
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

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 3 · 203 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0031-8655	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8655	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8655	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0031-8753	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8753	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8753	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0031-8754	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8754	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8754	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0031-8755	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0031-8755	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Wyeth Consumer Healthcare LLC	ANDA	Current
0031-8755	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex	Richmond Division of Wyeth	ANDA	Current
0113-0384	good sense cough dm	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0384	good sense cough dm	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0384	good sense cough dm	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0384	good sense cough dm	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0958	Good Sense Cough DM	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0958	Good Sense Cough DM	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-0958	Good Sense Cough DM	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0113-7384	basic care cough DM	dextromethorphan polistirex	L. Perrigo Company	ANDA	Current
0363-0384	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0384	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0384	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0494	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0494	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0494	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0899	childrens cough dm	Dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0899	childrens cough dm	Dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0899	childrens cough dm	Dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0958	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0363-0958	Cough DM	dextromethorphan polistirex	Walgreen Company	ANDA	Current
0904-6312	cough dm	dextromethorphan polistirex	Major Pharmaceuticals	ANDA	Current
0904-6312	cough dm	dextromethorphan polistirex	Major Pharmaceuticals	ANDA	Current
0904-6312	cough dm	dextromethorphan polistirex	Major Pharmaceuticals	ANDA	Current
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex	Target Corporation	ANDA	Current
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex	Target Corporation	ANDA	Current
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex	Target Corporation	ANDA	Current
11822-0384	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0384	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0384	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0494	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0494	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0494	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0958	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0958	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
11822-0958	Cough DM	dextromethorphan polistirex	Rite Aid Corporation	ANDA	Current
17856-6312	cough dm	dextromethorphan polistirex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6312	cough dm	dextromethorphan polistirex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6312	cough dm	dextromethorphan polistirex	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
21130-012	signature care 12 hour cough relief	dextromethorphan polistirex	Safeway	ANDA	Current
21130-012	signature care 12 hour cough relief	dextromethorphan polistirex	Safeway	ANDA	Current
21130-012	signature care 12 hour cough relief	dextromethorphan polistirex	Safeway	ANDA	Current
21130-520	Signature Care Cough Relief	dextromethorphan polistirex	Safeway	ANDA	Current
21130-890	signature care childrens 12 hour cough relief	Dextromethorphan polistirex	Safeway	ANDA	Current
30142-384	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-384	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-384	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-384	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-494	cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-494	cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-494	cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-494	cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-793	childrens cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-793	childrens cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-793	childrens cough dm	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-958	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
30142-958	Cough DM	dextromethorphan polistirex	Kroger Company	ANDA	Current
36800-494	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-494	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-494	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-494	TopCare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current
36800-552	Topcare Cough DM	dextromethorphan polistirex	Topco Associates LLC	ANDA	Current

Documents#

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