Application 204528

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMIVUDINE	LAMIVUDINE	TABLET;ORAL	150MG	No	No
002	LAMIVUDINE	LAMIVUDINE	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204528-001	LAMIVUDINE	LAMIVUDINE	150MG	TABLET / ORAL			2016-03-04
A204528-002	LAMIVUDINE	LAMIVUDINE	300MG	TABLET / ORAL			2016-03-04

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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204528-001	LAMIVUDINE	150MG	TABLET / ORAL	2016-03-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204528-002	LAMIVUDINE	300MG	TABLET / ORAL	2016-03-04	`3a93d1ddd44b…`

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.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	6bd6b9da-df69-46db-813e-4e7f3bdecf95	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
LAMIVUDINE	LAMIVUDINE	Major Pharmaceuticals	6fd4d6b9-65ea-4988-8d6f-dd220ec5052d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMIVUDINE generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Strides Pharma Science Limited	ac824c7e-9c9f-487b-ad2f-d50eaef5cbda	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
lamivudine	LAMIVUDINE ORAL	Chartwell Govermental & Specialty RX, LLC.	b23aea53-324b-4ff2-8736-639e4045e388	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamivudine
lamivudine	LAMIVUDINE ORAL	Chartwell RX, LLC	ef9977cb-ec91-46d7-b769-d26decfd6fe7	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamivudine
LAMIVUDINE	LAMIVUDINE	Golden State Medical Supply, Inc.	f3637209-303e-4232-ae79-07315a990973	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMIVUDINE generic name: LAMIVUDINE
LAMIVUDINE	LAMIVUDINE	Apotex Corp.	34c02bcc-d6ff-99d4-8e6a-4a91908adca8	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMIVUDINE generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Golden State Medical Supply, Inc.	3c30216d-f9f5-104b-e063-6294a90af8fd	2025-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Apotex Corp.	87095352-c088-74b1-7be0-d3e293a90611	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Coupler LLC	2d7db3b2-9b3c-3031-e063-6294a90a342c	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	e90671c6-7fff-48f4-8898-29f02d049c8b	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	49d53e74-3798-4463-b817-1c8beb755034	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	American Health Packaging	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Aurobindo Pharma Limited	a8a492ab-396a-4b7c-99b3-bcb6d3386f71	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Rising Pharma Holdings, Inc.	bed2e227-8d36-40ea-bbbf-d8793bfda425	2024-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Aurobindo Pharma Limited	ba7ee31e-e8d4-4e17-b27a-d2ce69e3bb00	2024-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Lupin Pharmaceuticals, Inc.	ff3b5265-f533-4332-a861-d8c9c1664ffd	2024-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Macleods Pharmaceuticals Limited	1be30bcc-2d9f-4afc-8f09-adc840b3f2d9	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Ingenus Pharmaceuticals, LLC	47f8be59-178c-4bad-96a4-a5c82784f308	2018-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamivudine generic name: LAMIVUDINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0513	Lamivudine	lamivudine	REMEDYREPACK INC.	ANDA	Current
70518-0540	Lamivudine	lamivudine	REMEDYREPACK INC.	ANDA	Current