Natco Thalidomide ANDA 213267 Approved April 24
Summary
The FDA granted approval to NATCO for Abbreviated New Drug Application (ANDA) 213267, covering Thalidomide capsules in 50mg, 100mg, and 200mg strengths, all designated Prescription status with TE Code AB. A prior approval action on 04/27/2023 (ORIG-1) covered the same 50mg strength. The 150mg strength is listed as Discontinued. NATCO's product is not designated as the Reference Listed Drug (RLD), which remains Bristol-Myers Squibb's THALOMID.
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What changed
The FDA approved ANDA 213267 for Thalidomide capsules at three active strengths (50mg, 100mg, 200mg) under Prescription status. The approval is coded as STANDARD review priority with no orphan status. A second approval action dated 04/24/2026 (ORIG-2) appears alongside the original 04/27/2023 approval, suggesting a supplement or amendment was approved. The 150mg strength remains listed as Discontinued.
Pharmaceutical companies and healthcare providers sourcing generic thalidomide should note that NATCO's product carries no RLD status, meaning Bristol-Myers Squibb's THALOMID remains the reference listed drug. Thalidomide is subject to a REMS program, which applies to both the brand and generic versions. Generic substitution under the AB TE Code designation is permitted in most jurisdictions.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 213267
Company: NATCO
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THALIDOMIDE | THALIDOMIDE | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| THALIDOMIDE | THALIDOMIDE | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
| THALIDOMIDE | THALIDOMIDE | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
| THALIDOMIDE | THALIDOMIDE | 200MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/2026 | ORIG-2 | Approval | STANDARD | Label is not available on this site. | |||
| 04/27/2023 | ORIG-1 | Approval | STANDARD | Letter (PDF) | Label is not available on this site. | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213267Orig1s000ltr.pdf |
THALIDOMIDE
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| THALIDOMIDE | THALIDOMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 213267 | NATCO |
| THALOMID | THALIDOMIDE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 020785 | BRISTOL-MYERS |
CAPSULE;ORAL; 100MG
TE Code = AB
| THALIDOMIDE | THALIDOMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213267 | NATCO |
| THALOMID | THALIDOMIDE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020785 | BRISTOL-MYERS |
CAPSULE;ORAL; 200MG
TE Code = AB
| THALIDOMIDE | THALIDOMIDE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213267 | NATCO |
| THALOMID | THALIDOMIDE | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 020785 | BRISTOL-MYERS |
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