Application 021041
- Type
- NDA
- Sponsor
- PACIRA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPOCYT | CYTARABINE | INJECTABLE, LIPOSOMAL;INJECTION | 10MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021041-001 | DEPOCYT | CYTARABINE | 10MG/ML | INJECTABLE, LIPOSOMAL / INJECTION | RLD | 1999-04-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021041-001 | DEPOCYT | 10MG/ML | INJECTABLE, LIPOSOMAL / INJECTION | RLD | 1999-04-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021041-001 | DEPOCYT | 10MG/ML | INJECTABLE, LIPOSOMAL / INJECTION | RLD | 1999-04-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021041-001 | DEPOCYT | 10MG/ML | INJECTABLE, LIPOSOMAL / INJECTION | RLD | 1999-04-01 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021041-001 | DEPOCYT | 10MG/ML | INJECTABLE, LIPOSOMAL / INJECTION | RLD | 1999-04-01 | 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 |
|---|---|---|---|---|---|---|
| Cytarabine | CYTARABINE | Hospira, Inc. | e3a8c0e9-19ed-49b7-8464-11e8806f47fd | 2025-04-07 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Meitheal Pharmaceuticals Inc. | 8105e590-fc7e-45b7-9604-c2d0d1be5eac | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| cytarabine | CYTARABINE | Sagent Pharmaceuticals | 90f5c7ab-9f15-487d-ba69-ee4107434bcc | 2023-05-31 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| cytarabine | CYTARABINE | Sagent Pharmaceuticals | 9bc7f6c2-4b16-449b-b383-76106540206c | 2023-05-22 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Meitheal Pharmaceuticals Inc. | 8b366382-c8d1-4344-86b7-f65e92a8952b | 2022-08-29 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Meitheal Pharmaceuticals Inc. | 1be2668b-d76f-4c65-aea9-86c5c40889a2 | 2022-07-06 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Meitheal Pharmaceuticals Inc. | 446f6765-5375-6368-4755-4944574f5721 | 2022-01-14 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Gland Pharma Limited | cb0db038-4a65-42c7-aa79-5c88309061df | 2020-07-14 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
| Cytarabine | CYTARABINE | Gland Pharma Limited | 7ab50348-ca78-46a5-aba6-c35b6b21fbfe | 2020-07-13 | Boxed warning, Warnings, Adverse reactions | CYTARABINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.