Application 219557
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.2% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219557-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219557-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219557-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A219557-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A219557-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 | fd3edfee7708… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219557-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | 2025-02-28 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Eye Allergy Itch Relief | EYE ALLERGY ITCH RELIEF | Allegiant Health | b40bf37a-da62-4ef7-8722-33a3a0f67c64 | 2026-05-26 | Warnings | 219557 ANDA219557 |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | BluePoint Laboratories | 3e86783f-0001-625f-e063-6294a90acd20 | 2026-03-25 | Warnings | 219557 ANDA219557 |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | AmerisourceBergen Drug Corp | 18f851e3-24c6-44fd-8376-0f5418ded9a9 | 2026-02-16 | Warnings | 219557 ANDA219557 |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | YYBA Corp | 47f8ae9b-d92b-4bcb-e063-6294a90af45a | 2026-02-03 | Warnings | 219557 ANDA219557 |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | GLENMARK THERAPEUTICS INC., USA | 07e8b359-d4ae-4b5b-81dc-c7e57e172c58 | 2026-01-27 | Warnings | 219557 ANDA219557 |