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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`cb3db0bc1861…`

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
12 hr relief cough dm	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	03c44e2f-d6e3-4c78-9c9a-92d1708a62fe	2026-07-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Equate Cough DM	DEXTROMETHORPHAN POLISTIREX	Wal-Mart Stores Inc	956fcc21-9e0f-41e3-9304-f379364a7d1c	2026-06-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
leader childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	3a468feb-da54-4a2c-bfce-bfe99f77efc3	2026-06-25	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CHILDRENS 12 HR COUGH RELIEF	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c	2026-06-17	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
12 HR RELIEF COUGH DM	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d63fff6c-a1cd-4636-b1d3-ae83be40c3f7	2026-06-03	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
up and up 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Target Corporation	a8acec73-dc66-444e-9438-370893cd5129	2026-05-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 11673-114
COUGH DM	DEXTROMETHORPHAN POLISTIREX	Safeway	58dab2f1-27b5-4522-bdc6-b710f20802eb	2026-05-04	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Major Pharmaceuticals	cdb5616e-0f04-4b9e-a82b-994e9ba3b515	2026-04-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 0904-6312
Leader Cough DM	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	a07b70d0-3842-4ea6-abb4-95b4638d5e55	2026-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Rite Aid Corporation	0b92c230-e86f-4e2f-9330-6a85de61eaf0	2026-03-24	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 11822-0494
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	ce7dafc6-1c23-40d2-94d0-2568298fd7ff	2026-03-06	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	20c10d74-0435-4e8a-acd7-5af1f8382c28	2026-01-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
DG Health Cough DM	DEXTROMETHORPHAN POLISTIREX	Dolgencorp Inc	648ca6b2-d31f-4941-baad-0f2accd30a9e	2026-01-21	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	6bdfa599-7898-4c05-927c-52fb82e0e686	2026-01-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
TopCare Cough DM	DEXTROMETHORPHAN POLISTIREX	Topco Associates LLC	490f695c-e60f-43db-b3f3-a9ffbb2906dd	2025-12-10	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 36800-494
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	db2e79f7-827f-45da-85ba-f3a774251070	2025-12-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	317ab8e0-c329-4d4e-9fd0-4bff4e1504cd	2025-11-20	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 0363-0899
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	043072e5-b92d-4fed-bfd8-aea07956806b	2025-11-14	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
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 ndc (product): 0113-0384
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 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