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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 21130-520
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
basic care cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	a0f35883-9dd3-49e7-87ac-ce04561ad6c3	2021-03-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Kroger Company	d98aa017-88db-4fe6-a260-ad6f3d8e23ea	2020-09-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 30142-494
DG Health Cough DM	DEXTROMETHORPHAN POLISTIREX	Dolgencorp, LLC	949e8907-860e-4f36-a840-d63d2bae3348	2020-07-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
equate cough dm	DEXTROMETHORPHAN POLISTIREX	Wal-Mart Stores Inc	5f72c4ad-1c30-41ea-b39c-7f4bb3deced6	2020-07-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Good Neighbor Pharmacy Cough DM ER	DEXTROMETHORPHAN POLISTIREX	Amerisource Bergen	4b23739b-5fae-4348-a387-c23dcde90b8b	2020-07-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CareOne Cough DM	DEXTROMETHORPHAN POLISTIREX	American Sales Company	2543912b-e6dd-46ca-8f0e-12603f6c28a7	2020-07-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Kroger Company	95051fe4-b42d-4395-b8d0-6889cc6d2fab	2020-05-28	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135 ndc (product): 30142-384
Cough DM	DEXTROMETHORPHAN POLISTIREX	CVS Pharmacy	956f0bd4-3266-4754-9bd2-ac480e3bcbce	2020-05-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CareOne Cough DM	DEXTROMETHORPHAN POLISTIREX	American Sales Company	42f67a3c-8cd7-44a6-8e54-08fb8449e8d7	2019-12-09	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