Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | None | No | No |
FAMOTIDINE | FAMOTIDINE | 20MG | 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 |
---|---|---|---|---|---|---|---|
11/17/2009 | 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 |
---|---|---|---|---|---|
05/11/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/02/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FAMOTIDINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 20MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077351 | PERRIGO R AND D |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 090283 | SUN PHARM INDS LTD |
FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 090837 | WOCKHARDT |
PEPCID AC | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | J AND J CONSUMER INC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA LTD |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075512 | P AND L |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075400 | PERRIGO |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 090283 | SUN PHARM INDS LTD |
FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077146 | WOCKHARDT |
PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | J AND J CONSUMER INC |
PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 020902 | J AND J CONSUMER INC |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English