Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091382
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | AB | No | No |
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | AB | No | No |
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/20/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091382Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/17/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LIOTHYRONINE SODIUM
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 | 218070 | BIOCON PHARMA |
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | DR REDDYS LABS SA |
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 | 218070 | BIOCON PHARMA |
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | DR REDDYS LABS SA |
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 | 218070 | BIOCON PHARMA |
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET;ORAL | Prescription | No | AB | 090097 | DR REDDYS LABS SA |
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 |