Application 210327
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210327-001 | DOCETAXEL | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | |
| A210327-002 | DOCETAXEL | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | |
| A210327-003 | DOCETAXEL | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210327-001 | AP |
| A210327-002 | AP |
| A210327-003 | 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 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-002 | DOCETAXEL | 80MG/4ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-003 | DOCETAXEL | 160MG/8ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210327-001 | DOCETAXEL | 20MG/ML (20MG/ML) | INJECTABLE / INJECTION | AP | 2019-05-16 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210327-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210327-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210327-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210327-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210327-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210327-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210327-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210327-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210327-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210327-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210327-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210327-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210327-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210327-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210327-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210327-001 | 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 ANHYDROUS | Mylan Institutional LLC | 2992d633-08fa-44f3-b14d-41700f24686b | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 81686d37-a13f-46e2-b439-a84eb1433634 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| BEIZRAY | DOCETAXEL | Zydus Pharmaceuticals USA Inc. | 8fb7d980-d6c7-468b-a9f0-adff16101a4b | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | DOCETAXEL |
| BEIZRAY | DOCETAXEL | Zhuhai Beihai Biotech Co., Ltd. | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | DOCETAXEL |
| Docetaxel | DOCETAXEL ANHYDROUS | Sagent Pharmaceuticals | 30077f79-341f-4618-9ec5-23b17b212fae | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL | Baxter Healthcare Corporation | 654319ae-e5f9-4a6a-b566-201923153b6e | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| DOCIVYX | DOCETAXEL | Avyxa Pharma, LLC | 4763744e-360e-4d37-be05-cce4114548cd | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | DOCETAXEL |
| Docetaxel | DOCETAXEL | Meitheal Pharmaceuticals Inc. | f970e352-3d43-4cc4-a859-503ec37b6e22 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Hospira, Inc. | 6b9999bb-869e-4d25-838c-23c3ab280044 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | 644c5035-20d2-4686-beaa-bef08e99051c | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | 00c61d11-d6b7-4618-b6f6-2592dbcc8af7 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL | Sanofi-Aventis U.S. LLC | dd0ca36d-1f54-4568-8d19-a7152addcd52 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Hospira, Inc. | 3104aab1-cd6e-4ad2-8e0a-286a0c5d1940 | 2024-09-19 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL ANHYDROUS | Hospira, Inc. | a0ec4bcc-93ea-4c41-a4b6-95ec19491807 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| DOCETAXEL | DOCETAXEL | Accord Healthcare Inc. | f59f7811-70b7-4c44-99f7-4f4fdce3ed22 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | DOCETAXEL DOCETAXEL |
| Docetaxel | DOCETAXEL | Actavis Pharma, Inc. | 2c806400-5fdc-4398-8475-37f700b3191f | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Eugia US LLC | 1263799c-13dc-488b-b158-b834736a4e66 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Mylan Institutional LLC | a6417655-9448-4886-ba03-f57f36bcbd14 | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Hikma Pharmaceuticals USA Inc. | ff7fb2c2-97a7-4716-a269-925ca30cf0f1 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Baxter Healthcare Corporation | 0e0f06bd-d190-45da-be8b-062e8de01970 | 2023-11-21 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |