Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215744
Company: ALEMBIC
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/28/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/12/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
DOCETAXEL
INJECTABLE;INJECTION; 20MG/2ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210072 | MYLAN LABS LTD |
| DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |
INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210848 | MYLAN LABS LTD |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207563 | NOVAST LABS |
| DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |
INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215744 | ALEMBIC |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214575 | EUGIA PHARMA |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213510 | GLAND PHARMA LTD |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 022234 | HOSPIRA INC |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209634 | MEITHEAL |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208859 | MYLAN LABS LTD |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207563 | NOVAST LABS |
| DOCETAXEL | DOCETAXEL | 160MG/16ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201525 | SANDOZ |