phytonadione · Pai Holdings Pharm · NDA 012223
Aquamephyton
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 216852, Baxter Hlthcare Corp · 012223-001Approved 26 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 215090, Sunny · 012223-001Approved 9 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216298, Orbicular · 012223-001Approved 13 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 215820, Dr Reddys · 012223-001Approved 15 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216601, Amneal · 012223-001Approved 4 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219175, Lupin · 012223-001Approved 30 Sep 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217734, Amneal · 012223-001Approved 1 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 012223 · 001 · RLD · discontinued | injectable, injection | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 012223 · 002 · RLD · discontinued | injectable, injection | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |