Application 050475
- Type
- NDA
- Sponsor
- VALEANT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 125MG | Yes | No |
| 002 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 250MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050475-001 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N050475-002 | GRIS-PEG | GRISEOFULVIN, ULTRAMICROSIZE | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050475-001 | AB |
| N050475-002 | AB |
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 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050475-001 | GRIS-PEG | 125MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050475-002 | GRIS-PEG | 250MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050475-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050475-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050475-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050475-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050475-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050475-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050475-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050475-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050475-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050475-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050475-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050475-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050475-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050475-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050475-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050475-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050475-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050475-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050475-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050475-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050475-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050475-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050475-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050475-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050475-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050475-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050475-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050475-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050475-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050475-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050475-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050475-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050475-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050475-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050475-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050475-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050475-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050475-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050475-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050475-002 | AB | 1 | 782e0a99824c… |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0884-0763 | Gris-PEG | griseofulvin | Pedinol Pharmacal, Inc. | NDA | Current |
| 0884-0773 | Gris-PEG | griseofulvin | Pedinol Pharmacal, Inc. | NDA | Current |
| 53808-0261 | Gris-PEG | GRISEOFULVIN | State of Florida DOH Central Pharmacy | NDA | Current |
| 68682-519 | Griseofulvin | Griseofulvin | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-520 | Griseofulvin | Griseofulvin | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |