Application 200890
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | SOLUTION;OPHTHALMIC | 1% | Yes | No |
| 002 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | SOLUTION;OPHTHALMIC | 2% | Yes | No |
| 003 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | SOLUTION;OPHTHALMIC | 4% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200890-001 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 |
| N200890-002 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | 2% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 |
| N200890-003 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE | 4% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N200890-001 | AT |
| N200890-002 | AT |
| N200890-003 | AT |
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 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-002 | ISOPTO CARPINE | 2% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-003 | ISOPTO CARPINE | 4% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N200890-001 | ISOPTO CARPINE | 1% | SOLUTION / OPHTHALMIC | AT | RLD, RS | 2010-06-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N200890-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200890-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200890-003 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200890-003 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200890-003 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200890-003 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200890-003 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200890-003 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200890-003 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200890-003 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200890-003 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200890-003 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200890-003 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-001 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-002 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200890-003 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-001 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-002 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200890-003 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N200890-001 | AT | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Sandoz Inc | 53fa0b7a-f982-48a7-92c4-6f098683c1ed | 2020-05-19 | Warnings, Adverse reactions | 200890 NDA200890 61314-203 61314-204 61314-206 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0998-0203 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0203 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0203 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0203 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0204 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0204 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0204 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0204 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0206 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0206 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0206 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 0998-0206 | ISOPTO CARPINE | pilocarpine hydrochloride | Alcon Laboratories, Inc. | NDA | Current |
| 21695-368 | PILOCARPINE HYDROCHLORIDE | PILOCARPINE HYDROCHLORIDE | Rebel Distributors Corp | NDA | Current |
| 61314-203 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-203 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 61314-203 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-203 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-204 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-204 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 61314-204 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-204 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-206 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-206 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 61314-206 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 61314-206 | Pilocarpine Hydrochloride | pilocarpine hydrochloride | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |