Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040734
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
METHIMAZOLE | METHIMAZOLE | 10MG | 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 |
---|---|---|---|---|---|---|---|
12/14/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/18/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
01/15/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
METHIMAZOLE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 218149 | BIONPHARMA |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 040411 | CHARTWELL RX |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 040734 | HERITAGE PHARMA |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 209827 | MACLEODS PHARMS LTD |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 040350 | MYLAN |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 040547 | QINGDAO BAHEAL PHARM |
METHIMAZOLE | METHIMAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 202068 | RISING |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 218149 | BIONPHARMA |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 040411 | CHARTWELL RX |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 040734 | HERITAGE PHARMA |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 209827 | MACLEODS PHARMS LTD |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 040350 | MYLAN |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 040547 | QINGDAO BAHEAL PHARM |
METHIMAZOLE | METHIMAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 202068 | RISING |