Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210118
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
07/15/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210118Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/03/2024 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/18/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/25/2020 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ICATIBANT ACETATE
INJECTABLE;SUBCUTANEOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FIRAZYR | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 022150 | TAKEDA PHARMS USA |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 213773 | ALEMBIC |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 212446 | CIPLA |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 213521 | EUGIA PHARMA |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208317 | FRESENIUS KABI USA |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 211021 | JIANGSU HANSOH PHARM |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 212081 | NANG KUANG PHARM CO |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 210118 | TEVA PHARMS USA |
ICATIBANT ACETATE | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 211501 | WILSHIRE PHARMS INC |