PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Dorzolamide hydrochloride and timolol maleate ophthalmic solution
- Manufacturer
- FDC Limited
- Effective date
- 2019-11-15
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:30:25
Label at a glance#
ProductDorzolamide and Timolol
Active ingredientDORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Label structure1 sections
Label contents#
Full prescribing information#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DORZOLAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| TIMOLOL ANHYDROUS Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20230503 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791 | Product name | 4 | 20251208 |
| 973dd458-49b1-1bb1-62c6-b37c4b15fe1f | Product name | 5 | 20251121 |
| 73103a56-9f57-4f32-a306-a42bfa2fea36 | Product name | 1 | 20250505 |
| 425025fc-f910-4afe-815b-58d4486ed4f7 | Product name | 4 | 20250331 |
| 26c5ddae-5c69-622d-e599-5fd583634968 | Product name | 4 | 20250313 |
| ee780602-134c-4c60-a2f0-e973ba549cd4 | Product name | 2 | 20250304 |
| 03f77cb2-b4ad-3c11-8781-787b5ece4291 | Product name | 3 | 20240507 |
| 273981e4-09e7-45cc-967c-554f628ededf | Product name | 3 | 20230627 |
| 97dad5a2-c524-a7b5-dede-82edefe9ce62 | Product name | 7 | 20220929 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| d11e749b-f93e-0ce3-ceda-28fe03d8081d | Product name | 2 | 20190731 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55545-1007-1 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 55545-1007-1 | Dorzolamide and Timolol | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 1 | |
| 55545-1007-2 | Dorzolamide and Timolol | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | 1 | |
| 55545-1007-2 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55545-1007 | DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [FDC LIMITED] | 1 | Legacy NDC, 4 package rows | 20191116_3189b866-d8ba-4ffc-a51b-20a46ce9c361.zip |
Products#
Every source-derived product name is available through these pages.
- Dorzolamide and Timolol
- Dorzolamide Hydrochloride and Timolol Maleate
- MANNITOL
- SODIUM CITRATE
- BENZALKONIUM CHLORIDE
- SODIUM HYDROXIDE
- WATER
- DORZOLAMIDE HYDROCHLORIDE
- DORZOLAMIDE
- TIMOLOL MALEATE
- TIMOLOL ANHYDROUS
- HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
- HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55545-1007 | 55545-1007-1, 55545-1007-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| DORZOLAMIDE HYDROCHLORIDE | QZO5366EW7 | ACTIM |
| TIMOLOL MALEATE | P8Y54F701R | ACTIM |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | IACT |
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | ZYD53NBL45 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205295-001 | AT1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | 2019-06-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | 2019-06-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | 2019-06-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT1 | 2019-06-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205295-001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-06-13 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A205295-001 | AT1 | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A205295-001 | AT1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A205295-001 | AT1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205295-001 | AT1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205295-001 | AT1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205295-001 | AT1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205295-001 | AT1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205295-001 | AT1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205295-001 | AT1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205295-001 | AT1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205295-001 | AT1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205295-001 | AT1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205295-001 | AT1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205295-001 | AT1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205295-001 | AT1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205295-001 | AT1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205295-001 | AT1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205295-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205295-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205295-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205295-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205295-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205295-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205295-001 | AT | 1 | 87673890dc5c… |
| 2019-12-14 00:12 UTC | 2019-12 | A205295-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205295-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205295-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205295-001 | AT1 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A205295-001 | AT1 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A205295-001 | AT1 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205295-001 | AT1 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205295-001 | AT1 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205295-001 | AT1 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205295-001 | AT1 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A205295-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A205295-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205295-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A205295-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A205295-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205295-001 | AT | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 97619b26-b0db-db63-e053-2995a90abdba | 3189b866-d8ba-4ffc-a51b-20a46ce9c361 | 2019-11-15 | 97619b26-b0db-db63-e053-2995a90abdba 3189b866-d8ba-4ffc-a51b-20a46ce9c361 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.