Application 206046
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206046-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2017-07-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A206046-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2017-07-26 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206046-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2017-07-26 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206046-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2017-07-26 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206046-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2017-07-26 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A206046-001 | AT | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A206046-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206046-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206046-001 | AT | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution | OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION | WALGREEN COMPANY | 66e76ab2-360c-4738-8424-c89c81007d83 | 2025-12-16 | Warnings | 206046 ANDA206046 |
| Equate Olopatadine Hydrochloride Ophthalmic Solution | OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION | WAL-MART STORES, INC., | 010b0c92-21ad-4e96-ac14-14683131da17 | 2025-04-14 | Warnings | 206046 ANDA206046 |
| Olopatadine Hydrochloride | OLOPATADINE HYDROCHLORIDE | TARGET CORPORATION | 879f9cf8-d6bb-483b-a6a7-28aba8806493 | 2025-04-14 | Warnings | 206046 ANDA206046 |
| Olopatadine Hydrochloride Ophthalmic Solution | OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION | Bausch & Lomb Incorporated | 468f79e0-8096-434a-a8bd-948a3d203e2d | 2024-10-28 | Warnings | 206046 ANDA206046 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.