Key facts
| Sponsor | DR REDDYS |
|---|---|
| Brand name | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
| Generic name | unspecified |
| Dosage form | TABLET, EXTENDED RELEASE |
| Application number | ANDA220448 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows DR REDDYS as the sponsor of LORATADINE AND PSEUDOEPHEDRINE SULFATE, with the generic name recorded as unspecified and dosage form TABLET, EXTENDED RELEASE. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. This specific application is submission type ORIG (submission number 1) under application number ANDA220448, with a submission status date of 20260806. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
Regulatory context
This application was reviewed under FDA's ORIG submission pathway. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
DR REDDYS’s FDA history
Argus HQ has recorded 4 total FDA actions tied to DR REDDYS: 0 warning letters, 0 recalls, 4 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Is this product available now?
- FDA's record lists a submission status date of 20260806. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
- Does DR REDDYS have other FDA approval records?
- Yes. Argus HQ has recorded 4 total FDA actions tied to DR REDDYS, including 4 approval records.
- What is the FDA application number for this submission?
- FDA application number ANDA220448, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
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Related enforcement actions
Full FDA history for DR REDDYSCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Approval Record: LORATADINE AND PSEUDOEPHEDRINE SULFATE — DR REDDYS, ORIG (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/dr-reddys-anda220448-2026-08-06
"Approval Record: LORATADINE AND PSEUDOEPHEDRINE SULFATE — DR REDDYS, ORIG (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/dr-reddys-anda220448-2026-08-06.
Argus HQ Research. "Approval Record: LORATADINE AND PSEUDOEPHEDRINE SULFATE — DR REDDYS, ORIG (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed August 14, 2026. https://argushq.ai/approval/dr-reddys-anda220448-2026-08-06.
@misc{argushq_argushq_ai_approval_dr_reddys_anda220448_2026_08_06_2026,
title = {Approval Record: LORATADINE AND PSEUDOEPHEDRINE SULFATE — DR REDDYS, ORIG (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/dr-reddys-anda220448-2026-08-06},
note = {Accessed: August 14, 2026}
}Source: FDA.gov — Approvals ↗