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| ACETAMINOPHEN | ACETAMINOPHEN | 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | ||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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018337-001 | ACETAMINOPHEN | 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018337-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018337-002 | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018337-003 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | RLD | 1983-09-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018337-004 | INFANTS' FEVERALL | 80MG | SUPPOSITORY / RECTAL | RLD | 1992-08-26 | 5bbf6a4d5a75… |
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 |