Application 091135
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 30MG HYDROBROMIDE/5ML | No | No |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Sense Cough DM | DEXTROMETHORPHAN POLISTIREX | L. Perrigo Company | 5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea | 2026-08-27 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | 10f51748-17b1-459d-8cc6-acc4577290aa | 2026-08-20 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | 43a90c58-8a7b-47cb-91ed-4afa3ec5dfb3 | 2026-08-13 | Warnings | 091135 ANDA091135 |
| Equate Cough DM | DEXTROMETHORPHAN POLISTIREX | Wal-Mart Stores Inc | 956fcc21-9e0f-41e3-9304-f379364a7d1c | 2026-06-26 | Warnings | 091135 ANDA091135 |
| leader childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | 3a468feb-da54-4a2c-bfce-bfe99f77efc3 | 2026-06-25 | Warnings | 091135 ANDA091135 70000-0195 |
| CHILDRENS 12 HR COUGH RELIEF | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c | 2026-06-17 | Warnings | 091135 ANDA091135 |
| 12 HR RELIEF COUGH DM | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d63fff6c-a1cd-4636-b1d3-ae83be40c3f7 | 2026-06-03 | Warnings | 091135 ANDA091135 |
| up and up 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Target Corporation | a8acec73-dc66-444e-9438-370893cd5129 | 2026-05-11 | Warnings | 091135 ANDA091135 |
| COUGH DM | DEXTROMETHORPHAN POLISTIREX | Safeway | 58dab2f1-27b5-4522-bdc6-b710f20802eb | 2026-05-04 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Major Pharmaceuticals | cdb5616e-0f04-4b9e-a82b-994e9ba3b515 | 2026-04-13 | Warnings | 091135 ANDA091135 |
| Leader Cough DM | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | a07b70d0-3842-4ea6-abb4-95b4638d5e55 | 2026-04-08 | Warnings | 091135 ANDA091135 70000-0302 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | ce7dafc6-1c23-40d2-94d0-2568298fd7ff | 2026-03-06 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | 20c10d74-0435-4e8a-acd7-5af1f8382c28 | 2026-01-27 | Warnings | 091135 ANDA091135 |
| DG Health Cough DM | DEXTROMETHORPHAN POLISTIREX | Dolgencorp Inc | 648ca6b2-d31f-4941-baad-0f2accd30a9e | 2026-01-21 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 6bdfa599-7898-4c05-927c-52fb82e0e686 | 2026-01-02 | Warnings | 091135 ANDA091135 |
| TopCare Cough DM | DEXTROMETHORPHAN POLISTIREX | Topco Associates LLC | 490f695c-e60f-43db-b3f3-a9ffbb2906dd | 2025-12-10 | Warnings | 091135 ANDA091135 |
| foster and thrive 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Strategic Sourcing Services LLC | db2e79f7-827f-45da-85ba-f3a774251070 | 2025-12-09 | Warnings | 091135 ANDA091135 |
| childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Walgreen Company | 317ab8e0-c329-4d4e-9fd0-4bff4e1504cd | 2025-11-20 | Warnings | 091135 ANDA091135 |
| foster and thrive 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Strategic Sourcing Services LLC | 043072e5-b92d-4fed-bfd8-aea07956806b | 2025-11-14 | Warnings | 091135 ANDA091135 |
| good sense cough dm | DEXTROMETHORPHAN POLISTIREX | L. Perrigo Company | 1b11b25b-2716-45f9-830f-ddf622366e60 | 2025-11-02 | Warnings | 091135 ANDA091135 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59779-709 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-709 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-709 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-709 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-924 | cough dm | Dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-924 | cough dm | Dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-924 | cough dm | Dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-958 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-958 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 59779-958 | Cough DM | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 61715-113 | preferred plus cough dm | dextromethorphan polistirex | Kinray | ANDA | Current |
| 62011-0176 | Health Mart Cough DM | dextromethorphan polistirex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0176 | Health Mart Cough DM | dextromethorphan polistirex | McKesson | ANDA | Current |
| 62011-0176 | Health Mart Cough DM | dextromethorphan polistirex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0198 | Health Mart Cough DM | dextromethorphan polistirex | McKesson | ANDA | Current |
| 62011-0198 | Health Mart Cough DM | dextromethorphan polistirex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0251 | health mart cough dm | dextromethorphan polistirex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0251 | health mart cough dm | dextromethorphan polistirex | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0251 | health mart cough dm | dextromethorphan polistirex | McKesson | ANDA | Current |
| 69256-384 | Harris Teeter Cough DM | dextromethorphan polistirex | Harris Teeter, LLC | ANDA | Current |
| 69256-384 | Harris Teeter Cough DM | dextromethorphan polistirex | Harris Teeter, LLC | ANDA | Current |
| 69842-613 | Tussin 12 HR | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 69842-613 | Tussin 12 HR | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 69842-613 | Tussin 12 HR | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 69842-751 | Tussin 12 HR | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 69842-751 | Tussin 12 HR | dextromethorphan polistirex | CVS Pharmacy | ANDA | Current |
| 70000-0187 | Leader Cough DM | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0187 | Leader Cough DM | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0187 | Leader Cough DM | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0187 | Leader Cough DM | dextromethorphan polistirex | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0195 | leader childrens cough dm | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0195 | leader childrens cough dm | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0195 | leader childrens cough dm | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0195 | leader childrens cough dm | dextromethorphan polistirex | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0302 | Leader Cough | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0302 | Leader Cough | dextromethorphan polistirex | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0302 | Leader Cough | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 70000-0302 | Leader Cough | dextromethorphan polistirex | Cardinal Health | ANDA | Current |
| 72288-384 | basic care cough dm | dextromethorphan polistirex | Amazon.com Services LLC | ANDA | Current |
| 72288-494 | basic care cough dm | dextromethorphan polistirex | Amazon.com Services LLC | ANDA | Current |
| 72288-899 | basic care childrens cough dm | Dextromethorphan polistirex | Amazon.com Services LLC | ANDA | Current |
| 72288-958 | basic care childrens cough dm | dextromethorphan polistirex | Amazon.com Services LLC | ANDA | Current |
| 81522-958 | Caring Mill Childrens Cough DM | dextromethorphan polistirex | FSA Store Inc. | ANDA | Current |