Application 080364
- Type
- ANDA
- Sponsor
- PARKE DAVIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/ML | No | No |
| 002 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
| 003 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 75MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080364-001 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080364-002 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080364-003 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 |
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 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080364-002 | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080364-003 | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080364-001 | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| 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 |