Application 022234
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | Yes | Yes |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML (10MG/ML) | Yes | Yes |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/16ML (10MG/ML) | Yes | Yes |
| 004 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | Yes | No |
| 005 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | Yes | No |
| 006 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 120MG/6ML (20MG/ML) | Yes | No |
| 007 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022234-001 | DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 |
| N022234-002 | DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 |
| N022234-003 | DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 |
| N022234-004 | DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | |
| N022234-005 | DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | |
| N022234-006 | DOCETAXEL | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | |
| N022234-007 | DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022234-001 | AP |
| N022234-002 | AP |
| N022234-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-006 | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-007 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-006 | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-007 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-006 | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-007 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-006 | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-007 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-006 | DOCETAXEL | 120MG/6ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-007 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2017-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-003 | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2011-03-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-004 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-005 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | RLD | 2016-06-23 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022234-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022234-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022234-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022234-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022234-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022234-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022234-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022234-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022234-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022234-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022234-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022234-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022234-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022234-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022234-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022234-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022234-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022234-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022234-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022234-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022234-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022234-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022234-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022234-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022234-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022234-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022234-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022234-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022234-001 | AP | 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 |
|---|---|---|---|---|---|---|
| Docetaxel | DOCETAXEL | Hospira, Inc. | 6b9999bb-869e-4d25-838c-23c3ab280044 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 022234 NDA022234 0409-5068 0409-4235 0409-0365 |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | 644c5035-20d2-4686-beaa-bef08e99051c | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 022234 NDA022234 0409-7870 0409-1732 |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | 00c61d11-d6b7-4618-b6f6-2592dbcc8af7 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 022234 NDA022234 0409-0016 0409-2026 |
| Docetaxel | DOCETAXEL | Hospira, Inc. | 3104aab1-cd6e-4ad2-8e0a-286a0c5d1940 | 2024-09-19 | Boxed warning, Warnings, Adverse reactions | 022234 NDA022234 0409-0366 0409-0367 0409-0368 |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | a0ec4bcc-93ea-4c41-a4b6-95ec19491807 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 022234 NDA022234 0409-0201 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-0016 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0201 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-0365 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0365 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0366 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0367 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-0368 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-1732 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-2026 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-4235 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-4235 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-5068 | Docetaxel | DOCETAXEL | Hospira, Inc. | NDA | Current |
| 0409-7870 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-7870 | Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74268 | SUPPL | 2023-05-16 |
| 74260 | SUPPL | 2023-05-16 |
| 65355 | SUPPL | 2020-11-27 |
| 65331 | SUPPL | 2020-11-25 |
| 60561 | SUPPL | 2019-10-15 |
| 60560 | SUPPL | 2019-10-15 |
| 60559 | SUPPL | 2019-10-15 |
| 60557 | SUPPL | 2019-10-15 |
| 60556 | SUPPL | 2019-10-15 |
| 60555 | SUPPL | 2019-10-15 |
| 55748 | SUPPL | 2018-10-01 |
| 55620 | SUPPL | 2018-09-26 |
| 55106 | SUPPL | 2018-08-03 |
| 55095 | SUPPL | 2018-08-03 |
| 49889 | SUPPL | 2017-09-29 |
| 49874 | SUPPL | 2017-09-28 |
| 49666 | SUPPL | 2017-09-06 |
| 29432 | SUPPL | 2014-07-11 |
| 17108 | SUPPL | 2014-07-11 |
| 44709 | ORIG | 2011-12-08 |
| 42459 | ORIG | 2011-12-08 |
| 17107 | ORIG | 2011-03-11 |
| 7075 | ORIG | 2011-03-11 |
| 7074 | ORIG | 2008-08-13 |