Application 018337
- Type
- NDA
- Sponsor
- TARO PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 650MG | Yes | Yes |
| 002 | ACETAMINOPHEN | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 325MG | Yes | No |
| 003 | ACETAMINOPHEN | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 120MG | Yes | No |
| 004 | INFANTS' FEVERALL | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 80MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018337-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | ||
| N018337-002 | ACETAMINOPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | ||
| N018337-003 | ACETAMINOPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | |
| N018337-004 | INFANTS' FEVERALL | ACETAMINOPHEN | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, RS, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018337-001 | ACETAMINOPHEN | 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 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 |
|---|---|---|---|---|---|---|
| Feverall Jr. Strength | ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | 3561bbc3-53b0-4857-8b71-39e165ed95ce | 2026-09-03 | Warnings | 018337 NDA018337 51672-2116 |
| Feverall Childrens | ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | 861e2987-5473-45b0-b2a6-f980a9b0e809 | 2026-08-24 | Warnings | 018337 NDA018337 51672-2115 |
| Feverall Infants | ACETAMINOPHEN | Sun Pharmaceutical Industries, Inc. | 3ade895b-5dca-4d81-9415-8091923162ff | 2026-07-24 | Warnings | 018337 NDA018337 51672-2114 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51672-2114 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2114 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2115 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2115 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2116 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2116 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 51672-2117 | Feverall | Acetaminophen | Taro Pharmaceuticals U.S.A. Inc. | NDA | Current |
| 63629-8240 | Feverall | Acetaminophen | Bryant Ranch Prepack | NDA | Current |