Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077421
Company: LANNETT CO INC
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE | LORATADINE | 1MG/ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
06/29/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077421s000LTR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/07/2014 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/12/2014 | SUPPL-4 | Labeling |
Label is not available on this site. |
LORATADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SYRUP;ORAL; 1MG/ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CLARITIN | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | Yes | 020641 | BAYER HEALTHCARE LLC |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 208931 | AUROBINDO PHARMA LTD |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 210409 | HETERO LABS LTD III |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 077421 | LANNETT CO INC |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 075728 | PERRIGO |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 076805 | TARO |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 201865 | TARO |
LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Over-the-counter | No | 075815 | WOCKHARDT BIO AG |