Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074948
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 100MG | TABLET;ORAL | Over-the-counter | None | No | No |
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 06/19/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74948ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/26/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/2002 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/26/2002 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
CIMETIDINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 074948 | APOTEX |
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 075285 | L PERRIGO CO |
| TAGAMET HB | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | Yes | 020238 | MEDTECH PRODUCTS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 100MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 100MG | TABLET;ORAL | Over-the-counter | No | 074948 | APOTEX |