Application 050797
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZMAX | AZITHROMYCIN | FOR SUSPENSION, EXTENDED RELEASE;ORAL | EQ 2GM BASE/BOT | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050797-001 | ZMAX | AZITHROMYCIN | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 |
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 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N050797-001 | ZMAX | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD | 2005-06-10 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N050797-001 | 6984403 | 2024-02-14 | U-282 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N050797-001 | 7887844 | 2024-02-14 | Drug product | 2011-03-15 | 3f01610625f2… |
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 |
|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | A-S Medication Solutions | 405ab07f-7d1d-4552-ad3b-2a03be8e9949 | 2026-02-17 | Warnings, Adverse reactions | AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | 59c4b783-4ff7-4269-969b-58a10e12b12b | 2026-02-04 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Sportpharm LLC | 5f9e13f5-69ee-4220-90d9-31fa8660d880 | 2026-02-03 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Sportpharm LLC | 60ec2020-148b-4a2a-96f2-dd09c590ecbb | 2026-02-03 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | AvKARE | 16da30a2-d11c-7e8c-e063-6294a90a62e3 | 2026-01-13 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | AiPing Pharmaceutical, Inc. | d6fb42ed-7dac-4a7b-9964-d367dd47dd5c | 2026-01-10 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Redpharm Drug | 2fd25741-f014-3999-e063-6394a90acdd0 | 2025-12-27 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Redpharm Drug | 3745a0b0-7855-69eb-e063-6294a90ab6a8 | 2025-12-24 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Bionpharma Inc. | 859bb02c-a4bc-46fa-9fc9-def1219b5dfb | 2025-12-04 | Warnings, Adverse reactions | AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 714f6f55-278a-4fcf-8d4e-2ad9b43623a3 | 2025-11-20 | Warnings, Adverse reactions | AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals, Inc. | 3f7c7421-411d-c04e-e063-6394a90a4aa0 | 2025-09-23 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Zhejiang Poly Pharm. Co., Ltd. | 33d0a4eb-5076-65c6-e063-6394a90ac13a | 2025-08-22 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Alembic Pharmaceuticals Inc. | 4314da8a-40e5-4aba-a32b-57b4166ade30 | 2025-06-30 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | American Health Packaging | 6169e56c-10fb-448d-ab0f-14e54fcf2817 | 2025-06-12 | Warnings, Adverse reactions | AZITHROMYCIN |
| azithromycin | AZITHROMYCIN | Lannett Company, Inc. | a2b0c06b-e93d-f5aa-e053-2995a90ac9aa | 2025-05-13 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 47a8fd64-5a3d-490e-8ca8-5e6721c830cf | 2025-05-01 | Warnings, Adverse reactions | AZITHROMYCIN |
| azithromycin | AZITHROMYCIN | Proficient Rx LP | 25bc2e78-9d0d-41c6-a55e-a267d4457967 | 2025-04-01 | Warnings, Adverse reactions | AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | Direct_Rx | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 2025-01-22 | Warnings, Adverse reactions | AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | DirectRx | d564d91e-3039-c120-e053-2995a90ae6db | 2025-01-21 | Warnings, Adverse reactions | AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Zydus Lifesciences Limited | 0b63649d-558c-4250-90ee-af6e1e5c6d2c | 2025-01-09 | AZITHROMYCIN |
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 |
|---|---|---|---|---|---|
| 21695-444 | Zmax | azithromycin | Rebel Distributors Corp | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69396 | SUPPL | 2021-11-23 |
| 69387 | SUPPL | 2021-11-23 |
| 58416 | SUPPL | 2019-04-25 |
| 58405 | SUPPL | 2019-04-24 |
| 47840 | SUPPL | 2017-04-03 |
| 47795 | SUPPL | 2017-03-31 |
| 47186 | SUPPL | 2017-02-13 |
| 47170 | SUPPL | 2017-02-10 |
| 8318 | SUPPL | 2016-05-26 |
| 39363 | SUPPL | 2016-05-25 |
| 8317 | SUPPL | 2015-07-10 |
| 39362 | SUPPL | 2015-07-06 |
| 39360 | SUPPL | 2013-10-17 |
| 30585 | SUPPL | 2013-10-15 |
| 44210 | ORIG | 2013-03-12 |
| 30588 | SUPPL | 2013-02-21 |
| 18283 | SUPPL | 2013-02-21 |
| 18282 | SUPPL | 2012-03-06 |
| 30587 | SUPPL | 2012-03-05 |
| 39361 | SUPPL | 2011-09-20 |
| 18281 | SUPPL | 2011-09-20 |
| 18280 | SUPPL | 2011-09-20 |
| 30586 | SUPPL | 2011-06-10 |
| 30584 | SUPPL | 2011-06-10 |
| 8316 | SUPPL | 2011-06-10 |
| 18279 | SUPPL | 2008-10-09 |
| 8315 | SUPPL | 2008-10-09 |
| 8314 | SUPPL | 2007-11-08 |
| 39359 | SUPPL | 2007-11-07 |
| 42744 | ORIG | 2007-09-10 |
| 30583 | ORIG | 2005-06-14 |
| 18278 | ORIG | 2005-06-14 |
| 53182 | SUPPL | 1900-01-01 |
| 53181 | SUPPL | 1900-01-01 |