Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212680
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | AB | No | No |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | AB | No | No |
PIRFENIDONE | PIRFENIDONE | 534MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
05/18/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212680Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
PIRFENIDONE
TABLET;ORAL; 267MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESBRIET | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | Yes | AB | 208780 | GENENTECH INC |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212730 | ACCORD HLTHCARE |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212747 | AIZANT |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212708 | ALEMBIC |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212570 | AMNEAL |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212709 | APOTEX |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212674 | HETERO LABS LTD V |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212722 | LAURUS |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212680 | MICRO LABS |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212772 | MSN |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212560 | SANDOZ |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212078 | SCIEGEN PHARMS INC |
PIRFENIDONE | PIRFENIDONE | 267MG | TABLET;ORAL | Prescription | No | AB | 212759 | TEVA PHARMS USA |
TABLET;ORAL; 801MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESBRIET | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | Yes | AB | 208780 | GENENTECH INC |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212730 | ACCORD HLTHCARE |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212747 | AIZANT |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212708 | ALEMBIC |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212570 | AMNEAL |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212709 | APOTEX |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212674 | HETERO LABS LTD V |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212722 | LAURUS |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212680 | MICRO LABS |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212772 | MSN |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212560 | SANDOZ |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212078 | SCIEGEN PHARMS INC |
PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | No | AB | 212759 | TEVA PHARMS USA |