اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYTOMEL از شرکت KING PHARMS
New Drug Application (NDA): 010379
Company: KING PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/08/1956 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2020 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.pdf |
|
| 12/21/2018 | SUPPL-54 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010379s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010379Orig1s054Ltr.pdf |
||
| 05/17/2002 | SUPPL-47 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10379S047ltr.pdf |
||
| 02/27/2002 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/2001 | SUPPL-45 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10379s45ltr.pdf |
|
| 04/14/2001 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2000 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/28/1994 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/06/1990 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/07/1984 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/07/1984 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/16/1975 | SUPPL-14 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-54 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010379s054lbl.pdf | |
| 05/17/2002 | SUPPL-47 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf |
CYTOMEL
TABLET;ORAL; EQ 0.005MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | Yes | AB | 010379 | KING PHARMS |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | MAYNE PHARMA INC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 200295 | SIGMAPHARM LABS LLC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 091382 | SUN PHARM |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 211510 | TEVA PHARMS USA |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 214803 | ZYDUS |
TABLET;ORAL; EQ 0.025MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | Yes | AB | 010379 | KING PHARMS |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | MAYNE PHARMA INC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 200295 | SIGMAPHARM LABS LLC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 091382 | SUN PHARM |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 211510 | TEVA PHARMS USA |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 214803 | ZYDUS |
TABLET;ORAL; EQ 0.05MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | Yes | AB | 010379 | KING PHARMS |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | MAYNE PHARMA INC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 200295 | SIGMAPHARM LABS LLC |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 091382 | SUN PHARM |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 211510 | TEVA PHARMS USA |
| LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 214803 | ZYDUS |
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