Does DR REDDYS have other FDA approval records?

This is the only FDA action Argus HQ has on file for DR REDDYS so far. Argus ingests new FDA records daily.

What is the FDA application number for this submission?

FDA application number ANDA218035, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is PREDNISONE?

PREDNISONE is formulated as: TABLET, DELAYED RELEASE.

FDA Approves PREDNISONE — ORIG Submission by DR REDDYS, Not disclosed in the FDA record.

Key facts

Sponsor	DR REDDYS
Brand name	PREDNISONE
Generic name	unspecified
Dosage form	TABLET, DELAYED RELEASE
Application number	ANDA218035
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: DR REDDYS received ANDA approval for PREDNISONE (Not disclosed in the FDA record.) on 2026-06-26. Application number ANDA218035, submission type ORIG (submission 1). Dosage form: TABLET, DELAYED RELEASE. 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 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 DR REDDYS as the sponsor of PREDNISONE, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET, DELAYED 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 ANDA218035, with a submission status date of 20260626. 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.

DR REDDYS’s FDA history

Argus HQ has recorded 1 total FDA action tied to DR REDDYS: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

Does DR REDDYS have other FDA approval records?: This is the only FDA action Argus HQ has on file for DR REDDYS so far. Argus ingests new FDA records daily.
What is the FDA application number for this submission?: FDA application number ANDA218035, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is PREDNISONE?: PREDNISONE is formulated as: TABLET, DELAYED RELEASE.

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Full FDA history for DR REDDYS

Compiled 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.

APA

Argus HQ Research (2026). FDA Approves PREDNISONE — ORIG Submission by DR REDDYS, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-dr-reddys-anda218035-1

MLA

"FDA Approves PREDNISONE — ORIG Submission by DR REDDYS, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-dr-reddys-anda218035-1.

Chicago

Argus HQ Research. "FDA Approves PREDNISONE — ORIG Submission by DR REDDYS, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-dr-reddys-anda218035-1.

BibTeX

@misc{argushq_argushq_ai_approval_fda_approval_dr_reddys_anda218035_1_2026,
  title = {FDA Approves PREDNISONE — ORIG Submission by DR REDDYS, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/approval/fda-approval-dr-reddys-anda218035-1},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Approvals ↗