Application 070608
- Type
- ANDA
- Sponsor
- PERRIGO NEW YORK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 650MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070608-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 23780dab-91d8-434f-9342-f5f1ba0a3c0a | 2025-04-15 | Warnings | 070608 ANDA070608 |
| acetaminophen pain reliever fever reducer | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | b43974c3-4db9-4201-beee-b22596a2b241 | 2025-02-12 | Warnings | 070608 ANDA070608 45802-730 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.