Application 020353
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 375MG BASE | Yes | No |
| 002 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | Yes | No |
| 003 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 750MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020353-001 | NAPRELAN | NAPROXEN SODIUM | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 |
| N020353-002 | NAPRELAN | NAPROXEN SODIUM | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 |
| N020353-003 | NAPRELAN | NAPROXEN SODIUM | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020353-001 | AB |
| N020353-002 | AB |
| N020353-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-002 | NAPRELAN | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-003 | NAPRELAN | EQ 750MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1996-01-05 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020353-001 | NAPRELAN | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 1996-01-05 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020353-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020353-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020353-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020353-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020353-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020353-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020353-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020353-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020353-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020353-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020353-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020353-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020353-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020353-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020353-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020353-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Naprelan | NAPROXEN SODIUM | Upsher-Smith Laboratories, LLC | b8a51c9a-488e-4377-a041-436f6a2f8893 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 020353 NDA020353 |
| Naproxen Sodium | NAPROXEN SODIUM | Upsher-Smith Laboratories, LLC | 7c22a2d6-821c-4f83-aead-e756aed930e5 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 020353 NDA020353 |
| Naproxen Sodium | NAPROXEN SODIUM | Alvogen Inc. | 9225acaa-209f-958b-2c51-9a46995dec33 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 020353 NDA020353 47781-153 47781-155 47781-154 |
| Naprelan | NAPROXEN SODIUM | Almatica Pharma LLC | e633ff0b-eab7-f167-8d08-e9236e54042b | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 020353 NDA020353 52427-273 52427-274 52427-272 |
| Naproxen Sodium | NAPROXEN SODIUM | SA3, LLC | 313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9 | 2019-04-23 | Boxed warning, Warnings, Adverse reactions | 020353 NDA020353 69420-1375 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-905 | NAPRELAN | naproxen sodium | Rebel Distributors Corp | NDA | Current |
| 21695-906 | NAPRELAN | naproxen sodium | Rebel Distributors Corp | NDA | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 59630-375 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 59630-777 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 59630-850 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 69420-1375 | Naproxen Sodium | Naproxen Sodium | SA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 71800-020 | Naproxen Sodium | Naproxen Sodium | Innovida Phamaceutique Corporation | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80346 | SUPPL | 2024-11-25 |
| 80324 | SUPPL | 2024-11-22 |
| 80323 | SUPPL | 2024-11-22 |
| 67348 | SUPPL | 2021-05-03 |
| 67347 | SUPPL | 2021-05-03 |
| 67254 | SUPPL | 2021-04-29 |
| 59421 | SUPPL | 2019-07-23 |
| 59420 | SUPPL | 2019-07-23 |
| 59410 | SUPPL | 2019-07-23 |
| 49724 | SUPPL | 2017-09-13 |
| 2365 | SUPPL | 2016-05-12 |
| 2364 | SUPPL | 2016-05-12 |
| 34532 | SUPPL | 2016-05-11 |
| 12465 | SUPPL | 2016-05-11 |
| 43644 | ORIG | 2011-11-17 |
| 24809 | SUPPL | 2011-11-10 |
| 34531 | SUPPL | 2011-11-09 |
| 34530 | SUPPL | 2009-11-06 |
| 2363 | SUPPL | 2009-08-10 |
| 24808 | SUPPL | 2007-06-04 |
| 34529 | SUPPL | 2006-01-20 |
| 24807 | SUPPL | 2006-01-20 |
| 20601 | SUPPL | 2003-08-08 |