Application 080455
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 007 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | No | No |
| 008 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
| 009 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 75MG/ML | No | No |
| 010 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080455-007 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | |
| A080455-008 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | |
| A080455-009 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | |
| A080455-010 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080455-007 | AP |
| A080455-008 | AP |
| A080455-009 | AP |
| A080455-010 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A080455-007 | MEPERIDINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A080455-008 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A080455-009 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A080455-010 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080455-007 | MEPERIDINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080455-008 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080455-009 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080455-010 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080455-007 | MEPERIDINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080455-008 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080455-009 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080455-010 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | AP | Approved before 1982 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A080455-007 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A080455-008 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A080455-009 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A080455-010 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A080455-007 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A080455-008 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A080455-009 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A080455-010 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A080455-007 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A080455-008 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A080455-009 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A080455-010 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080455-007 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080455-008 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080455-009 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080455-010 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A080455-007 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A080455-008 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A080455-009 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A080455-010 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080455-007 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080455-008 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080455-009 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080455-010 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080455-007 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080455-008 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080455-009 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080455-010 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080455-007 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080455-008 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080455-009 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080455-010 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080455-007 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080455-008 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080455-009 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080455-010 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080455-007 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080455-008 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080455-009 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080455-010 | AP | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | b31d1308-28c3-43f4-e0a6-2f3ed76b8975 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 15bc51a8-1e24-4d33-9a2f-05a41c29acf0 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | Genus Lifesciences Inc. | 792fefda-6cc4-4709-b902-fd9787fc310a | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | EPIC PHARMA, LLC | fae5cc34-5917-4445-9516-25f97ffca8db | 2025-11-29 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e0e998da-f056-4fce-be8e-ed60cf3b461b | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.