Key facts
| Sponsor | ANNORA PHARMA |
|---|---|
| Brand name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Generic name | unspecified |
| Dosage form | ELIXIR |
| Application number | ANDA219470 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
Regulatory context
This application was reviewed under FDA's standard review pathway, which typically targets a 10-month review goal measured from submission. 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.
What was approved
FDA's record shows ANNORA PHARMA as the sponsor of DIPHENHYDRAMINE HYDROCHLORIDE, with the generic name recorded as Not disclosed in the FDA record. and dosage form ELIXIR. 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 ANDA219470, with a submission status date of 20260617. 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.
ANNORA PHARMA’s FDA history
Argus HQ has recorded 3 total FDA actions tied to ANNORA PHARMA: 0 warning letters, 0 recalls, 3 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What dosage form is DIPHENHYDRAMINE HYDROCHLORIDE?
- DIPHENHYDRAMINE HYDROCHLORIDE is formulated as: ELIXIR.
- What did FDA approve?
- FDA's record shows ANDA approval for DIPHENHYDRAMINE HYDROCHLORIDE (Not disclosed in the FDA record.), dosage form ELIXIR, sponsored by ANNORA PHARMA, under application number ANDA219470. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.
- What does the submission type mean?
- 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.
- Is this product available now?
- FDA's record lists a submission status date of 20260617. 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.
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Related enforcement actions
Full FDA history for ANNORA PHARMACompiled 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). ANNORA PHARMA — FDA ORIG Approval for DIPHENHYDRAMINE HYDROCHLORIDE (Not disclosed in the FDA record.). Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-annora-pharma-anda219470-1
"ANNORA PHARMA — FDA ORIG Approval for DIPHENHYDRAMINE HYDROCHLORIDE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-annora-pharma-anda219470-1.
Argus HQ Research. "ANNORA PHARMA — FDA ORIG Approval for DIPHENHYDRAMINE HYDROCHLORIDE (Not disclosed in the FDA record.)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-annora-pharma-anda219470-1.
@misc{argushq_argushq_ai_approval_fda_approval_annora_pharma_anda219470_1_2026,
title = {ANNORA PHARMA — FDA ORIG Approval for DIPHENHYDRAMINE HYDROCHLORIDE (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/approval/fda-approval-annora-pharma-anda219470-1},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Approvals ↗