Regulations.gov document
Annexure III - Copy of Agency’s Response to Controlled Correspondence Control No. 00158625…
Supporting & Related Material · FDA-2023-P-2339 · posted Jun 8, 2023
Key facts
| Document ID | FDA-2023-P-2339-0005 |
|---|---|
| Title | Annexure III - Copy of Agency’s Response to Controlled Correspondence Control No. 00158625 K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq where FDA suggested the applicant that any abbreviated new drug application (ANDA) submitted that refers to NDA RE Citizen Petition from Granules India Limited |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2023-P-2339 |
| Posted | Jun 8, 2023 |
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